TPLC - Total Product Life Cycle

• Device: system, image processing, radiological
• Product Code: LLZ
• Regulation Number: 892.2050
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
3D INDUSTRIAL IMAGING CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
3D INDUSTRIAL IMAGING CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
3D ONS, INC.
	SUBSTANTIALLY EQUIVALENT	1
3D SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
3DIEMME LTD.
	SUBSTANTIALLY EQUIVALENT	1
3SHAPE MEDICAL A/S
	SUBSTANTIALLY EQUIVALENT	1
ABYS MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
ACROVIZ INC.
	SUBSTANTIALLY EQUIVALENT	1
ADAS3D MEDICAL S.L
	SUBSTANTIALLY EQUIVALENT	3
ADM DIAGNOSTICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
ADVANTIS MEDICAL IMAGING SINGLE MEMBER P.C.
	SUBSTANTIALLY EQUIVALENT	2
AI MEDIC INC.
	SUBSTANTIALLY EQUIVALENT	1
AI MEDICAL AG
	SUBSTANTIALLY EQUIVALENT	1
AI METRICS, LLC
	SUBSTANTIALLY EQUIVALENT	1
AI4MEDIMAGING MEDICAL SOLUTIONS S.A.
	SUBSTANTIALLY EQUIVALENT	1
AIBOLIT TECHNOLOGIES, LLC
	SUBSTANTIALLY EQUIVALENT	2
AIQ SOLUTIONS, INC.
	SUBSTANTIALLY EQUIVALENT	1
AIRAMED GMBH
	SUBSTANTIALLY EQUIVALENT	1
AIRS MEDICAL INC.
	SUBSTANTIALLY EQUIVALENT	3
AKUNAH PTY LTD
	SUBSTANTIALLY EQUIVALENT	1
ALPHATEC SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	1
ALTARAVISION INC.
	SUBSTANTIALLY EQUIVALENT	1
AMCAD BIOMED CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
ANATOMAGE INC.
	SUBSTANTIALLY EQUIVALENT	1
ANGIOCLOUD, LLC
	SUBSTANTIALLY EQUIVALENT	1
APOLLO MEDICAL IMAGING TECHNOLOGY PTY. LTD.
	SUBSTANTIALLY EQUIVALENT	1
APOQLAR GMBH
	SUBSTANTIALLY EQUIVALENT	1
APTERYX, INC.
	SUBSTANTIALLY EQUIVALENT	1
ARGUS COGNITIVE, INC.
	SUBSTANTIALLY EQUIVALENT	1
ARTERYFLOW TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
ARTERYS INC.
	SUBSTANTIALLY EQUIVALENT	2
ARTHREX INC.
	SUBSTANTIALLY EQUIVALENT	1
ASCEND HIT
	SUBSTANTIALLY EQUIVALENT	1
ASSEMBLECIRCLE CORP.
	SUBSTANTIALLY EQUIVALENT	1
ATOMICA TECHNOLOGY, INC.
	SUBSTANTIALLY EQUIVALENT	1
AUGMENT INTELLIGENT MEDICAL SYSTEM (CHINA) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
AVATAR MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
AXIAL MEDICAL PRINTING LIMITED
	SUBSTANTIALLY EQUIVALENT	2
BAY LABS, INC.
	SUBSTANTIALLY EQUIVALENT	1
BB IMAGING
	SUBSTANTIALLY EQUIVALENT	2
BIOMET MANUFACTURING CORP.
	SUBSTANTIALLY EQUIVALENT	1
BLUE BELT TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
BODY VISION MEDICAL LTD.
	SUBSTANTIALLY EQUIVALENT	1
BRAID.HEALTH
	SUBSTANTIALLY EQUIVALENT	1
BRAINLAB AG
	SUBSTANTIALLY EQUIVALENT	3
BRAINLAB LTD.
	SUBSTANTIALLY EQUIVALENT	1
BRAINNOW MEDICAL TECHNOLOGY LIMITED
	SUBSTANTIALLY EQUIVALENT	1
BRAINOMIX LIMITED
	SUBSTANTIALLY EQUIVALENT	3
BRAINSPEC, INC
	SUBSTANTIALLY EQUIVALENT	1
CANON MEDICAL INFORMATICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
CANON MEDICAL SYSTEMS CORPORATION
	SUBSTANTIALLY EQUIVALENT	6
CARDIO FLOW DESIGN INC.
	SUBSTANTIALLY EQUIVALENT	1
CARDIOWISE, INC.
	SUBSTANTIALLY EQUIVALENT	1
CARISTO DIAGNOSTICS
	SUBSTANTIALLY EQUIVALENT	1
CARL ZEISS MEDITEC AG
	SUBSTANTIALLY EQUIVALENT	1
CARLSMED, INC.
	SUBSTANTIALLY EQUIVALENT	1
CARPL AI INC.
	SUBSTANTIALLY EQUIVALENT	1
CEDARS-SINAI MEDICAL CENTER: AIM
	SUBSTANTIALLY EQUIVALENT	1
CEEVRA, INC.
	SUBSTANTIALLY EQUIVALENT	1
CERCARE MEDICAL A/S
	SUBSTANTIALLY EQUIVALENT	1
CERCARE MEDICAL APS
	SUBSTANTIALLY EQUIVALENT	1
CEREMETRIX CORP
	SUBSTANTIALLY EQUIVALENT	1
CERTIS HEALTH
	SUBSTANTIALLY EQUIVALENT	1
CHANGE HEALTHCARE CANADA COMPANY
	SUBSTANTIALLY EQUIVALENT	1
CHANGE HEALTHCARE ISRAEL LTD.
	SUBSTANTIALLY EQUIVALENT	2
CIRCLE CARDIOVASCULAR IMAGING
	SUBSTANTIALLY EQUIVALENT	1
CIRCLE CARDIOVASCULAR IMAGING INC.
	SUBSTANTIALLY EQUIVALENT	1
CIRCLE CARDIOVASCULAR IMAGING, INC.
	SUBSTANTIALLY EQUIVALENT	1
CLARIPI INC.
	SUBSTANTIALLY EQUIVALENT	3
CLARITAS HEALTHTECH PTE LTD
	SUBSTANTIALLY EQUIVALENT	2
CLARUS VIEWER CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
CLEERLY INC
	SUBSTANTIALLY EQUIVALENT	1
CLEERLY, INC.
	SUBSTANTIALLY EQUIVALENT	1
CLIENT OUTLOOK INC.
	SUBSTANTIALLY EQUIVALENT	1
COMBINOSTICS OY
	SUBSTANTIALLY EQUIVALENT	1
CONVERGENT IMAGING SOLUTIONS
	SUBSTANTIALLY EQUIVALENT	1
CORELINE SOFT CO., LTD
	SUBSTANTIALLY EQUIVALENT	3
CORELINE SOFT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
CORIN USA
	SUBSTANTIALLY EQUIVALENT	4
CORIN USA LIMITED
	SUBSTANTIALLY EQUIVALENT	1
CORTICOMETRICS LLC
	SUBSTANTIALLY EQUIVALENT	1
COVIDIEN LLC.
	SUBSTANTIALLY EQUIVALENT	1
COVIDIEN, LLC
	SUBSTANTIALLY EQUIVALENT	1
CUPTIMIZE, INC.
	SUBSTANTIALLY EQUIVALENT	1
CURVEBEAM, LLC
	SUBSTANTIALLY EQUIVALENT	1
DALIAN SENYINT DIGITAL MEDICAL SYSTEM CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
DDE MRI SOLUTIONS LTD
	SUBSTANTIALLY EQUIVALENT	1
DE GOTZEN S.R.L
	SUBSTANTIALLY EQUIVALENT	1
DEEPLOOK INC.
	SUBSTANTIALLY EQUIVALENT	1
DEEPTEK MEDICAL IMAGING PRIVATE LIMITED
	SUBSTANTIALLY EQUIVALENT	1
DENSITAS, INC.
	SUBSTANTIALLY EQUIVALENT	2
DENTI.AI TECHNOLOGY INC.
	SUBSTANTIALLY EQUIVALENT	1
DENTSPLY SIRONA
	SUBSTANTIALLY EQUIVALENT	1
DEPUY ORTHOPAEDICS, INC
	SUBSTANTIALLY EQUIVALENT	1
DICOM GRID DBA AMBRA HEALTH
	SUBSTANTIALLY EQUIVALENT	1
DICOM GRID, INC, DBA AMBRA HEALTH
	SUBSTANTIALLY EQUIVALENT	1
DIGITALCORE CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
DISIOR LTD
	SUBSTANTIALLY EQUIVALENT	2
DOSISOFT
	SUBSTANTIALLY EQUIVALENT	1
DRGEM CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
DRTECH CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
DURR DENTAL SE
	SUBSTANTIALLY EQUIVALENT	3
DÜRR DENTAL SE
	SUBSTANTIALLY EQUIVALENT	1
DYAD MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
EBM TECHNOLOGIES INC.
	SUBSTANTIALLY EQUIVALENT	1
ECHOPIXEL INC.
	SUBSTANTIALLY EQUIVALENT	1
ECHOPIXEL, INC.
	SUBSTANTIALLY EQUIVALENT	1
EIGEN
	SUBSTANTIALLY EQUIVALENT	1
ELUCID BIOIMAGING INC.
	SUBSTANTIALLY EQUIVALENT	2
EOS IMAGING
	SUBSTANTIALLY EQUIVALENT	2
EVER FORTUNE.AI CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
EVERRTECH SOFTWARE PVT LTD
	SUBSTANTIALLY EQUIVALENT	1
EVOLVE PACS INC.
	SUBSTANTIALLY EQUIVALENT	1
EWOO SOFT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	5
EWOOSOFT CO., LTD
	SUBSTANTIALLY EQUIVALENT	9
EWOOSOFT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	4
EXINI DIAGNOSTICS AB
	SUBSTANTIALLY EQUIVALENT	3
EXOCAD GMBH
	SUBSTANTIALLY EQUIVALENT	2
EZRA AI, INC.
	SUBSTANTIALLY EQUIVALENT	1
FH INDUSTRIE
	SUBSTANTIALLY EQUIVALENT	2
FOCAL HEALTHCARE INC.
	SUBSTANTIALLY EQUIVALENT	1
FUJIFILM CORPORATION
	SUBSTANTIALLY EQUIVALENT	6
FUJIFILM CORPORATON
	SUBSTANTIALLY EQUIVALENT	1
GALGO MEDICAL S.L
	SUBSTANTIALLY EQUIVALENT	1
GE HEALTHCARE
	SUBSTANTIALLY EQUIVALENT	5
GE MEDICAL SYSTEMS SCS
	SUBSTANTIALLY EQUIVALENT	7
GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGNOSTICS,LLC
	SUBSTANTIALLY EQUIVALENT	1
GE MEDICAL SYSTEMS ULTRASOUND AND
	SUBSTANTIALLY EQUIVALENT	1
GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY
	SUBSTANTIALLY EQUIVALENT	1
GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIAGNOSTICS
	SUBSTANTIALLY EQUIVALENT	1
GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIAGNOSTICS,
	SUBSTANTIALLY EQUIVALENT	1
HARMONUS INC.
	SUBSTANTIALLY EQUIVALENT	1
HDX WILL CORP.
	SUBSTANTIALLY EQUIVALENT	2
HERMES MEDICAL SOLUTIONS AB
	SUBSTANTIALLY EQUIVALENT	1
HEURON CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3
HINACOM SOFTWARE AND TECHNOLOGY, LTD
	SUBSTANTIALLY EQUIVALENT	1
HOLOGIC, INC.
	SUBSTANTIALLY EQUIVALENT	1
HOTH INTELLIGENCE INC.
	SUBSTANTIALLY EQUIVALENT	1
HURA IMAGING, INC.
	SUBSTANTIALLY EQUIVALENT	1
HYPERFINE RESEARCH, INC
	SUBSTANTIALLY EQUIVALENT	1
IAID
	SUBSTANTIALLY EQUIVALENT	1
IB LAB GMBH
	SUBSTANTIALLY EQUIVALENT	1
ICAD, INC
	SUBSTANTIALLY EQUIVALENT	1
ICAT SOLUTIONS LTD
	SUBSTANTIALLY EQUIVALENT	1
ICOMETRIX
	SUBSTANTIALLY EQUIVALENT	1
ICOMETRIX NV
	SUBSTANTIALLY EQUIVALENT	3
IGI TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	1
IMAGE INSTRUMENTS GMBH
	SUBSTANTIALLY EQUIVALENT	1
IMAGING BIOMETRICS, LLC
	SUBSTANTIALLY EQUIVALENT	1
IMAGING WAVE, LLC
	SUBSTANTIALLY EQUIVALENT	1
IMBIO, LLC
	SUBSTANTIALLY EQUIVALENT	1
IMMERSIVETOUCH
	SUBSTANTIALLY EQUIVALENT	1
IMMERSIVETOUCH, INC.
	SUBSTANTIALLY EQUIVALENT	1
IMPLANTER LLC
	SUBSTANTIALLY EQUIVALENT	1
IN-MED PROGNOSTICS L3C
	SUBSTANTIALLY EQUIVALENT	1
INFINITT HEALTHCARE CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	2
INHEART, SAS
	SUBSTANTIALLY EQUIVALENT	1
INTELERAD MEDICAL SYSTEMS INCORPORATED
	SUBSTANTIALLY EQUIVALENT	1
INTELLIJOINT SURGICAL INC.
	SUBSTANTIALLY EQUIVALENT	1
INTER MEDICAL MEDIZINTECHNIK GMBH
	SUBSTANTIALLY EQUIVALENT	1
INTERNATIONAL MEDICAL SOLUTIONS INC.
	SUBSTANTIALLY EQUIVALENT	1
INTEWARE CO. LTD.
	SUBSTANTIALLY EQUIVALENT	1
INTUITIVE SURGICAL
	SUBSTANTIALLY EQUIVALENT	1
INVIVO CORPORATION
	SUBSTANTIALLY EQUIVALENT	4
INVIZ CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
IONIC HEALTH
	SUBSTANTIALLY EQUIVALENT	1
IRM INC
	SUBSTANTIALLY EQUIVALENT	1
ISCHEMA VIEW INC.
	SUBSTANTIALLY EQUIVALENT	2
ISCHEMAVIEW, INC.
	SUBSTANTIALLY EQUIVALENT	2
JOINTVUE LLC
	SUBSTANTIALLY EQUIVALENT	1
KINEPICT HEALTH LTD
	SUBSTANTIALLY EQUIVALENT	2
KONICA MINOLTA HEALTHCARE AMERICAS, INC.
	SUBSTANTIALLY EQUIVALENT	1
KONICA MINOLTA, INC.
	SUBSTANTIALLY EQUIVALENT	4
LAZARUS 3D
	SUBSTANTIALLY EQUIVALENT	1
LAZARUS, 3D, INC
	SUBSTANTIALLY EQUIVALENT	1
LEAD TECHNOLOGIES INC.
	SUBSTANTIALLY EQUIVALENT	1
LENTO MEDICAL INNOVATION, INC.
	SUBSTANTIALLY EQUIVALENT	1
LEXI CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
LG ELECTRONICS
	SUBSTANTIALLY EQUIVALENT	1
LG ELECTRONICS INC.
	SUBSTANTIALLY EQUIVALENT	1
LG ELECTRONICS.INC
	SUBSTANTIALLY EQUIVALENT	1
LIMBUS AI INC.
	SUBSTANTIALLY EQUIVALENT	2
MATERIALISE N.V.
	SUBSTANTIALLY EQUIVALENT	2
MATERIALISE NV
	SUBSTANTIALLY EQUIVALENT	3
MDAI INC
	SUBSTANTIALLY EQUIVALENT	1
MEDACTA INTERNATIONAL S.A.
	SUBSTANTIALLY EQUIVALENT	1
MEDACTA INTERNATIONAL SA
	SUBSTANTIALLY EQUIVALENT	3
MEDAPP S.A.
	SUBSTANTIALLY EQUIVALENT	1
MEDDIFF TECHNOLOGIES PVT. LTD.
	SUBSTANTIALLY EQUIVALENT	1
MEDIC VISION - IMAGING SOLUTIONS LTD
	SUBSTANTIALLY EQUIVALENT	1
MEDICAD HECTEC GMBH
	SUBSTANTIALLY EQUIVALENT	2
MEDICAL TEMPLATES AG
	SUBSTANTIALLY EQUIVALENT	1
MEDICALCOMMUNICATIONS GMBH
	SUBSTANTIALLY EQUIVALENT	1
MEDICALIP CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
MEDICREA INTERNATIONAL
	SUBSTANTIALLY EQUIVALENT	1
MEDICREA INTERNATIONAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDILAB MANUTENCAO E SITEMAS LTDA
	SUBSTANTIALLY EQUIVALENT	1
MEDISO MEDICAL IMAGING SYSTEMS, LTTD.
	SUBSTANTIALLY EQUIVALENT	1
MEDIVIEW XR, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDIVIS, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDSYNAPTIC PRIVATE LTD
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC NAVIGATION INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDVISO AB
	SUBSTANTIALLY EQUIVALENT	1
MEGAGEN IMPLANT CO. LTD
	SUBSTANTIALLY EQUIVALENT	1
MEGAGEN IMPLANT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
MERGE HEALTHCARE INCORPORATED
	SUBSTANTIALLY EQUIVALENT	4
MIM SOFTWARE INC.
	SUBSTANTIALLY EQUIVALENT	4
MINT LABS, INC., D/B/A. QMENTA
	SUBSTANTIALLY EQUIVALENT	1
MIRADA MEDICAL LTD
	SUBSTANTIALLY EQUIVALENT	2
MIRADA MEDICAL LTD.
	SUBSTANTIALLY EQUIVALENT	1
MIRRORME3D, LLC
	SUBSTANTIALLY EQUIVALENT	1
MOTILENT LTD
	SUBSTANTIALLY EQUIVALENT	1
MULTIFUNCTIONAL IMAGING, LLC
	SUBSTANTIALLY EQUIVALENT	1
MULTIMODAL IMAGING SERVICES CORPORATION (DBA HEALTHLYTIX)
	SUBSTANTIALLY EQUIVALENT	1
NAVISWISS AG
	SUBSTANTIALLY EQUIVALENT	1
NESA MEDTECH PRIVATE LIMITED
	SUBSTANTIALLY EQUIVALENT	1
NEUROPHET, INC.
	SUBSTANTIALLY EQUIVALENT	2
NICO-LAB B.V.
	SUBSTANTIALLY EQUIVALENT	1
NINES, INC.
	SUBSTANTIALLY EQUIVALENT	1
NOBEL BIOCARE AB
	SUBSTANTIALLY EQUIVALENT	5
NORDICNEUROLAB AS
	SUBSTANTIALLY EQUIVALENT	1
NOVARAD CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
NUCLEUSHEALTH, LLC
	SUBSTANTIALLY EQUIVALENT	1
NUVASIVE, INCORPORATED
	SUBSTANTIALLY EQUIVALENT	1
O.N. DIAGNOSTICS, LLC.
	SUBSTANTIALLY EQUIVALENT	1
O3 ENTERPRISE SRL
	SUBSTANTIALLY EQUIVALENT	1
OLEA MEDICAL
	SUBSTANTIALLY EQUIVALENT	4
OLEA MEDICAL SAS
	SUBSTANTIALLY EQUIVALENT	1
OMNISCIENT NEUROTECHNOLOGY PTY LTD (O8T)
	SUBSTANTIALLY EQUIVALENT	2
ONEFIT MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
ONEPACS, LLC
	SUBSTANTIALLY EQUIVALENT	1
OPENRAD SERVICES UK LTD
	SUBSTANTIALLY EQUIVALENT	1
OPTIMA HEALTH SOLUTIONS INTERNATIONAL CORP.
	SUBSTANTIALLY EQUIVALENT	1
ORCA DENTAL AI LTD
	SUBSTANTIALLY EQUIVALENT	1
ORTHO2, LLC
	SUBSTANTIALLY EQUIVALENT	1
ORTHOFIX SRL
	SUBSTANTIALLY EQUIVALENT	1
ORTHOFIX US LLC
	SUBSTANTIALLY EQUIVALENT	1
ORTHOGRID SYSTEMS INC.
	SUBSTANTIALLY EQUIVALENT	2
ORTHOGRID SYSTEMS, INC
	SUBSTANTIALLY EQUIVALENT	1
ORTHOSOFT D/B/A ZIMMER CAS
	SUBSTANTIALLY EQUIVALENT	2
ORTHOSOFT, INC (D/B/A ZIMMER CAS)
	SUBSTANTIALLY EQUIVALENT	1
ORTHOSOFT, INC. (D/B/A ZIMMER CAS)
	SUBSTANTIALLY EQUIVALENT	2
ORYX DENTAL SOFTWARE INC
	SUBSTANTIALLY EQUIVALENT	1
OVERJET, INC.
	SUBSTANTIALLY EQUIVALENT	1
PATTERSON DENTAL SUPPLY, INC
	SUBSTANTIALLY EQUIVALENT	1
PATTERSON DENTAL SUPPLY, INC.
	SUBSTANTIALLY EQUIVALENT	1
PEEK HEALTH, S.A.
	SUBSTANTIALLY EQUIVALENT	2
PERCEPTION VISION MEDICAL TECHNOLOGIES LTD.CO.
	SUBSTANTIALLY EQUIVALENT	1
PERSPECTUM
	SUBSTANTIALLY EQUIVALENT	2
PERSPECTUM DIAGNOSTICS LTD
	SUBSTANTIALLY EQUIVALENT	1
PERSPECTUM LTD.
	SUBSTANTIALLY EQUIVALENT	1
PHANTOMICS INC.
	SUBSTANTIALLY EQUIVALENT	1
PHILIPS HEALTHCARE
	SUBSTANTIALLY EQUIVALENT	3
PHILIPS HEALTHCARE INFORMATICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
	SUBSTANTIALLY EQUIVALENT	3
PHILIPS MEDICAL SYSTEMS NEDERLAND BV
	SUBSTANTIALLY EQUIVALENT	1
PHILIPS MEDICAL SYSTEMS TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	1
PHILIPS MEDICAL SYSTEMS TECHNOLOGIES, LTD.
	SUBSTANTIALLY EQUIVALENT	1
PHILIPS ULTRASOUND INC.
	SUBSTANTIALLY EQUIVALENT	1
PHILIPS ULTRASOUND, INC
	SUBSTANTIALLY EQUIVALENT	1
PHILIPS ULTRASOUND, INC.
	SUBSTANTIALLY EQUIVALENT	2
PIE MEDICAL IMAGING B.V.
	SUBSTANTIALLY EQUIVALENT	3
PIXEE MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
PIXYL SA
	SUBSTANTIALLY EQUIVALENT	1
PLANMECA OY
	SUBSTANTIALLY EQUIVALENT	1
PLUM MEDICAL SOLUTIONS GMBH
	SUBSTANTIALLY EQUIVALENT	1
POLAREAN, INC.
	SUBSTANTIALLY EQUIVALENT	1
PRECISIONOS TECHNOLOGY INC.
	SUBSTANTIALLY EQUIVALENT	1
PRODIGIDENT, INC.
	SUBSTANTIALLY EQUIVALENT	1
PROKNOW LLC
	SUBSTANTIALLY EQUIVALENT	1
PYMEDIX
	SUBSTANTIALLY EQUIVALENT	1
QLARITY IMAGING
	SUBSTANTIALLY EQUIVALENT	1
QUANTIB B.V.
	SUBSTANTIALLY EQUIVALENT	1
QUANTIB BV
	SUBSTANTIALLY EQUIVALENT	6
QUIBIM S.L.
	SUBSTANTIALLY EQUIVALENT	1
QYNAPSE
	SUBSTANTIALLY EQUIVALENT	1
RADICAL IMAGING, LLC
	SUBSTANTIALLY EQUIVALENT	1
RADIOBOTICS APS
	SUBSTANTIALLY EQUIVALENT	1
RADISEN CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
RAMSOFT INC.
	SUBSTANTIALLY EQUIVALENT	1
RAYENCE CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
RAYENCE CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1
REAL VIEW IMAGING LTD.
	SUBSTANTIALLY EQUIVALENT	1
REALIZE MEDICAL INC.
	SUBSTANTIALLY EQUIVALENT	1
RESOUNDANT INC
	SUBSTANTIALLY EQUIVALENT	1
RICOH USA, INC.
	SUBSTANTIALLY EQUIVALENT	2
ROLOGY INC.
	SUBSTANTIALLY EQUIVALENT	1
S.M.A.I.O
	SUBSTANTIALLY EQUIVALENT	1
S.M.A.I.O.
	SUBSTANTIALLY EQUIVALENT	1
SAMSUNG MEDISON CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SEE-MODE TECHNOLOGIES PTE. LTD.
	SUBSTANTIALLY EQUIVALENT	1
SEGANA, INC.
	SUBSTANTIALLY EQUIVALENT	1
SEGANA, LLC
	SUBSTANTIALLY EQUIVALENT	1
SENTIAR, INC
	SUBSTANTIALLY EQUIVALENT	1
SENTIAR, INC.
	SUBSTANTIALLY EQUIVALENT	1
SHANGHAI UNITED IMAGING HEALTHCARE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	4
SHANGHAI UNITED IMAGING HEALTHCARE CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	3
SICAT GMBH & CO. KG
	SUBSTANTIALLY EQUIVALENT	2
SIEMENS HEALTHCARE GMBH
	SUBSTANTIALLY EQUIVALENT	9
SIEMENS MEDICAL SOLUTION USA, INC.
	SUBSTANTIALLY EQUIVALENT	2
SIEMENS MEDICAL SOLUTIONS USA INC.
	SUBSTANTIALLY EQUIVALENT	2
SIEMENS MEDICAL SOLUTIONS USA, INC.
	SUBSTANTIALLY EQUIVALENT	11
SIEMENS MEDICAL SOLUTIONS, INC
	SUBSTANTIALLY EQUIVALENT	1
SIEMENS MEDICAL SOLUTIONS, USA INC.
	SUBSTANTIALLY EQUIVALENT	1
SIEMENS MEDICAL SOLUTIONS, USA, INC.
	SUBSTANTIALLY EQUIVALENT	1
SIEMENS MEDICAL SOULTIONS USA, INC.
	SUBSTANTIALLY EQUIVALENT	2
SIGMA SCIENTIFIC SERVICES LLC
	SUBSTANTIALLY EQUIVALENT	1
SINGULAR HEALTH PTY LTD
	SUBSTANTIALLY EQUIVALENT	1
SIRA MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
SOFTNETA UAB
	SUBSTANTIALLY EQUIVALENT	1
SOFTWARE NEMOTEC S.L.
	SUBSTANTIALLY EQUIVALENT	2
SOTA PRECISION OPTICS, INC. DBA SOTA IMAGING
	SUBSTANTIALLY EQUIVALENT	1
SPECTRUM DYNAMICS MEDICAL LTD
	SUBSTANTIALLY EQUIVALENT	1
STATLIFE
	SUBSTANTIALLY EQUIVALENT	1
STRYKER CORP.
	SUBSTANTIALLY EQUIVALENT	1
SUBTLE MEDICAL INC.
	SUBSTANTIALLY EQUIVALENT	1
SUBTLE MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	3
SURGICAL INFORMATION SCIENCES, INC.
	SUBSTANTIALLY EQUIVALENT	3
SURGICAL THEATER, INC.
	SUBSTANTIALLY EQUIVALENT	1
SURGICAL THEATER, LLC
	SUBSTANTIALLY EQUIVALENT	1
SYNAPTIVE MEDICAL INC.
	SUBSTANTIALLY EQUIVALENT	1
SYNOPSYS (NORTHERN EUROPE) LTD.
	SUBSTANTIALLY EQUIVALENT	1
TECHFIT DIGITAL SURGERY INC.
	SUBSTANTIALLY EQUIVALENT	1
TECHHEIM CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
TERARECON INC.
	SUBSTANTIALLY EQUIVALENT	1
TERARECON INC.,
	SUBSTANTIALLY EQUIVALENT	1
TERARECON, INC
	SUBSTANTIALLY EQUIVALENT	1
TERARECON, INC.
	SUBSTANTIALLY EQUIVALENT	1
THE METHODIST HOSPITAL RESEARCH INSTITUTE D/B/A HOUSTON
	SUBSTANTIALLY EQUIVALENT	1
TOMTEC IMAGING SYSTEMS GMBH
	SUBSTANTIALLY EQUIVALENT	1
TOSHIBA MEDICAL SYSTEMS CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
TRANSLATIONAL MRI, LLC
	SUBSTANTIALLY EQUIVALENT	1
TROPHY
	SUBSTANTIALLY EQUIVALENT	1
UC-CARE LTD.
	SUBSTANTIALLY EQUIVALENT	1
VARIAN MEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
VENTRIPOINT DIAGNOSTICS, LTD.
	SUBSTANTIALLY EQUIVALENT	1
VISIBLE PATIENT, SAS
	SUBSTANTIALLY EQUIVALENT	1
VISUS HEALTH IT GMBH
	SUBSTANTIALLY EQUIVALENT	4
VITAL IMAGES, INC.
	SUBSTANTIALLY EQUIVALENT	2
VIZ.AI, INC.
	SUBSTANTIALLY EQUIVALENT	1
VOLPARA HEALTH TECHNOLOGIES LIMITED
	SUBSTANTIALLY EQUIVALENT	2
VOXIMETRY, INCORPORATED
	SUBSTANTIALLY EQUIVALENT	1
VUZE MEDICAL LTD.
	SUBSTANTIALLY EQUIVALENT	1
XIRONETIC, LLC
	SUBSTANTIALLY EQUIVALENT	1
XORAN TECHNOLOGIES LLC
	SUBSTANTIALLY EQUIVALENT	1
YIWEI MEDICAL TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
YUKUN (BEIJING) TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ZEBRA MEDICAL VISION LTD.
	SUBSTANTIALLY EQUIVALENT	1
ZED TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	1
ZETTA MEDICAL TECHNOLOGIES, LLC.
	SUBSTANTIALLY EQUIVALENT	1
ZIOSOFT, INC.
	SUBSTANTIALLY EQUIVALENT	2
ZIRKONZAHN SRL
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2018	72	72
2019	88	88
2020	82	82
2021	70	70
2022	28	28
2023	26	26
2024	7	7

Device Problems	MDRs with this Device Problem	Events in those MDRs
Loss of Data	110	110
Computer Software Problem	105	105
Use of Device Problem	71	71
Data Problem	35	35
Application Program Problem: Parameter Calculation Error	29	29
Adverse Event Without Identified Device or Use Problem	25	25
Patient Data Problem	20	20
Improper or Incorrect Procedure or Method	16	16
Application Program Problem	13	13
Insufficient Information	8	8
No Apparent Adverse Event	7	7
Data Back-Up Problem	6	6
Image Display Error/Artifact	5	5
Application Program Freezes, Becomes Nonfunctional	5	5
No Display/Image	4	4
Incorrect, Inadequate or Imprecise Result or Readings	4	4
Defective Component	3	3
Inadequate User Interface	3	3
Missing Test Results	3	3
Output Problem	3	3
Problem with Software Installation	2	2
Unexpected Shutdown	2	2
Device Issue	2	2
Communication or Transmission Problem	2	2
Device Displays Incorrect Message	2	2
Incorrect Measurement	2	2
Display or Visual Feedback Problem	2	2
Failure to Back-Up	2	2
Break	1	1
Image Orientation Incorrect	1	1
Electrical /Electronic Property Problem	1	1
Mechanical Problem	1	1
Poor Quality Image	1	1
Device Inoperable	1	1
Loss of Power	1	1
Failure to Power Up	1	1
Unable to Obtain Readings	1	1
Failure to Transmit Record	1	1
Operating System Becomes Nonfunctional	1	1
Device Ingredient or Reagent Problem	1	1
Electrical Power Problem	1	1
Human Factors Issue	1	1
Improper Device Output	1	1
Computer Operating System Problem	1	1
Connection Problem	1	1
Application Program Version or Upgrade Problem	1	1
Battery Problem	1	1
Defective Device	1	1
No Visual Prompts/Feedback	1	1
Unintended Application Program Shut Down	1	1
Program or Algorithm Execution Failure	1	1
Programming Issue	1	1
Reset Problem	1	1
Therapeutic or Diagnostic Output Failure	1	1
Wireless Communication Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	144	144
No Clinical Signs, Symptoms or Conditions	143	143
No Consequences Or Impact To Patient	48	48
No Patient Involvement	8	8
Insufficient Information	8	8
Misdiagnosis	4	4
No Information	3	3
Ruptured Aneurysm	2	2
Thrombosis/Thrombus	2	2
Stenosis	2	2
Pneumonia	2	2
Pneumothorax	2	2
Aortic Valve Stenosis	2	2
Bacterial Infection	2	2
Death	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Unintended Radiation Exposure	2	2
Radiation Overdose	1	1
Dyspnea	1	1
Endocarditis	1	1
Hematoma	1	1
Hemoptysis	1	1
Hemorrhage/Bleeding	1	1
Pain	1	1
Pleural Effusion	1	1
Chest Pain	1	1
Cyst(s)	1	1
Scar Tissue	1	1
Radiation Underdose	1	1
Ambulation Difficulties	1	1
Vascular System (Circulation), Impaired	1	1
Brain Injury	1	1
Viral Infection	1	1
Foreign Body In Patient	1	1
Patient Problem/Medical Problem	1	1
Device Embedded In Tissue or Plaque	1	1
Not Applicable	1	1
Unspecified Heart Problem	1	1
Cough	1	1
Unspecified Tissue Injury	1	1
No Code Available	1	1
Missing Value Reason	1	1
Cancer	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	AS Software, Inc.	II	Oct-16-2018
2	Agfa Healthcare NV	II	Jan-20-2023
3	Agfa Healthcare NV	II	Oct-11-2018
4	Brainreader ApS	II	Jan-29-2021
5	CHANGE HEALTHCARE CANADA COMPANY	II	Dec-14-2023
6	CHANGE HEALTHCARE CANADA COMPANY	II	Nov-06-2023
7	CHANGE HEALTHCARE CANADA COMPANY	II	Jun-02-2021
8	CHANGE HEALTHCARE CANADA COMPANY	II	Apr-28-2021
9	CHANGE HEALTHCARE CANADA COMPANY	II	Oct-08-2020
10	DICOM Grid, Inc. d/b/a Ambra Health	II	Sep-27-2022
11	Digisonics, Inc	II	Jul-20-2023
12	EOS Imaging	II	Sep-18-2018
13	Exocad GmbH	II	Sep-25-2023
14	FUJIFILM Healthcare Americas Corporation	II	Mar-07-2024
15	FUJIFILM Healthcare Americas Corporation	II	Feb-21-2024
16	Fujifilm Medical Systems U.S.A., Inc.	II	Jun-02-2021
17	Fujifilm Medical Systems U.S.A., Inc.	II	Apr-02-2021
18	Fujifilm Medical Systems U.S.A., Inc.	II	Jan-22-2021
19	Fujifilm Medical Systems U.S.A., Inc.	II	Jan-17-2021
20	Fujifilm Medical Systems U.S.A., Inc.	II	Oct-22-2020
21	Fujifilm Medical Systems U.S.A., Inc.	II	Jun-30-2020
22	GE Healthcare	II	Oct-23-2023
23	GE Healthcare	II	Oct-20-2023
24	GE Healthcare	II	May-02-2023
25	GE Healthcare	II	Jun-06-2018
26	GE Healthcare	II	Apr-03-2018
27	GE Healthcare, LLC	II	Aug-24-2022
28	GE Healthcare, LLC	II	Jul-25-2022
29	GE Healthcare, LLC	II	Jul-05-2022
30	GE Healthcare, LLC	II	Jun-03-2022
31	GE Healthcare, LLC	II	Dec-02-2021
32	GE Healthcare, LLC	II	Oct-02-2021
33	GE Healthcare, LLC	II	Sep-22-2021
34	GE Healthcare, LLC	II	May-05-2021
35	GE Healthcare, LLC	II	Jan-17-2020
36	GE Healthcare, LLC	II	Jul-01-2019
37	GE Healthcare, LLC	II	Jun-26-2019
38	GE Healthcare, LLC	II	Jun-13-2019
39	GE Healthcare, LLC	II	Feb-01-2019
40	GE Healthcare, LLC	II	Dec-19-2018
41	GE Healthcare, LLC	II	Nov-02-2018
42	GE Healthcare, LLC	II	Oct-18-2018
43	GE Medical Systems, LLC	II	Dec-16-2022
44	Immersivetouch Inc	III	May-18-2020
45	Invivo Corporation	II	Apr-02-2018
46	Koios Medical, Inc.	II	Jan-17-2020
47	Konica Minolta Healthcare Americas, Inc.	II	Jan-14-2022
48	Konica Minolta Medical Imaging USA, Inc.	II	Jun-22-2018
49	Medtronic Navigation, Inc.	II	Sep-26-2018
50	Merge Healthcare, Inc.	II	Sep-09-2020
51	Merge Healthcare, Inc.	II	Jun-19-2020
52	Merge Healthcare, Inc.	II	Jul-23-2019
53	Merge Healthcare, Inc.	II	Oct-11-2018
54	NordicNeuroLab AS	II	Jul-25-2022
55	NordicNeuroLab AS	II	Jun-04-2018
56	NordicNeuroLab AS	II	Jun-01-2018
57	NordicNeuroLab AS	II	Jun-01-2018
58	NordicNeuroLab AS	II	May-31-2018
59	NordicNeuroLab AS	II	May-31-2018
60	Novarad Corporation	II	Sep-12-2020
61	OLEA MEDICAL	II	Oct-18-2023
62	Ortho Kinematics, Inc	II	Aug-22-2018
63	Ortho Kinematics, Inc	II	Aug-22-2018
64	Ortho Kinematics, Inc	II	Aug-22-2018
65	Ortho Kinematics, Inc	II	Aug-21-2018
66	Philips Healthcare Informatics, Inc.	II	Jun-10-2020
67	Philips North America, LLC	II	Jan-13-2021
68	Philips North America Llc	II	Apr-06-2022
69	SICAT GMBH & CO. KG	II	Sep-10-2020
70	Siemens Medical Solutions USA, Inc	II	May-09-2018
71	Siemens Medical Solutions USA, Inc	II	May-07-2018
72	Siemens Medical Solutions USA, Inc	II	Mar-28-2018
73	Siemens Medical Solutions USA, Inc	II	Mar-20-2018
74	Siemens Medical Solutions USA, Inc	II	Mar-01-2018
75	Siemens Medical Solutions USA, Inc	II	Feb-05-2018
76	Siemens Medical Solutions USA, Inc	II	Jan-31-2018
77	Siemens Medical Solutions USA, Inc.	II	Jan-23-2018
78	Simpleware Product Group, SYNOPSYS NORTHERN EUROPE	II	Aug-12-2021
79	Synaptive Medical Inc	II	Apr-22-2020
80	Tomtec Imaging Systems Gmbh	II	Jul-04-2020
81	Virtual Radiologic Corp.	II	Jul-21-2023