TPLC - Total Product Life Cycle

• Device: system, image processing, radiological
• Regulation Description: Medical image management and processing system.
• Product Code: LLZ
• Regulation Number: 892.2050
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
3D INDUSTRIAL IMAGING CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
3D ONS, INC.
	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
AIKENIST TECHNOLOGIES PVT LTD
	SUBSTANTIALLY EQUIVALENT	1
AIQ GLOBAL, 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
ANGIOCLOUD, LLC
	SUBSTANTIALLY EQUIVALENT	1
APOQLAR GMBH
	SUBSTANTIALLY EQUIVALENT	1
ARGUS COGNITIVE, INC.
	SUBSTANTIALLY EQUIVALENT	1
ARTERYFLOW TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
ARTHREX INC.
	SUBSTANTIALLY EQUIVALENT	1
ASCEND HIT
	SUBSTANTIALLY EQUIVALENT	1
ASPEN IMAGING HEALTHCARE INC
	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	2
AXIAL MEDICAL PRINTING LIMITED
	SUBSTANTIALLY EQUIVALENT	2
BB IMAGING
	SUBSTANTIALLY EQUIVALENT	2
BIOMET MANUFACTURING CORP.
	SUBSTANTIALLY EQUIVALENT	1
BLUE BELT TECHNOLOGIES, INC.
	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	4
BRAINSPEC, INC
	SUBSTANTIALLY EQUIVALENT	1
CANON MEDICAL INFORMATICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
CANON MEDICAL SYSTEMS CORPORATION
	SUBSTANTIALLY EQUIVALENT	4
CARDIO FLOW DESIGN INC.
	SUBSTANTIALLY EQUIVALENT	1
CARDIOWISE, INC.
	SUBSTANTIALLY EQUIVALENT	1
CARISTO DIAGNOSTICS
	SUBSTANTIALLY EQUIVALENT	1
CARISTO DIAGNOSTICS LTD.
	SUBSTANTIALLY EQUIVALENT	1
CARL ZEISS MEDITEC AG
	SUBSTANTIALLY EQUIVALENT	1
CARLSMED, INC.
	SUBSTANTIALLY EQUIVALENT	2
CARPL AI INC.
	SUBSTANTIALLY EQUIVALENT	1
CEDARS-SINAI MEDICAL CENTER: AIM
	SUBSTANTIALLY EQUIVALENT	1
CERCARE MEDICAL A/S
	SUBSTANTIALLY EQUIVALENT	2
CERCARE MEDICAL APS
	SUBSTANTIALLY EQUIVALENT	1
CHANGE HEALTHCARE CANADA COMPANY
	SUBSTANTIALLY EQUIVALENT	1
CHANGE HEALTHCARE ISRAEL LTD.
	SUBSTANTIALLY EQUIVALENT	1
CIRCLE CARDIOVASCULAR IMAGING
	SUBSTANTIALLY EQUIVALENT	1
CIRCLE CARDIOVASCULAR IMAGING INC.
	SUBSTANTIALLY EQUIVALENT	1
CIRCLE CARDIOVASCULAR IMAGING, INC.
	SUBSTANTIALLY EQUIVALENT	1
CLARIPI INC.
	SUBSTANTIALLY EQUIVALENT	2
CLARITAS HEALTHTECH PTE LTD
	SUBSTANTIALLY EQUIVALENT	2
CLARUS VIEWER CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
CLEERLY, INC.
	SUBSTANTIALLY EQUIVALENT	1
COMBINOSTICS OY
	SUBSTANTIALLY EQUIVALENT	1
CONVERGENT IMAGING SOLUTIONS
	SUBSTANTIALLY EQUIVALENT	1
CORELINE SOFT CO., LTD
	SUBSTANTIALLY EQUIVALENT	2
CORELINE SOFT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
CORIN USA
	SUBSTANTIALLY EQUIVALENT	3
CORIN USA LIMITED
	SUBSTANTIALLY EQUIVALENT	1
CORTICOMETRICS LLC
	SUBSTANTIALLY EQUIVALENT	1
CUPTIMIZE, INC.
	SUBSTANTIALLY EQUIVALENT	1
CUSTOMSURG AG
	SUBSTANTIALLY EQUIVALENT	1
CYNCRONUS LLC
	SUBSTANTIALLY EQUIVALENT	1
DDE MRI SOLUTIONS LTD
	SUBSTANTIALLY EQUIVALENT	1
DE GOTZEN S.R.L
	SUBSTANTIALLY EQUIVALENT	1
DEEPHEALTH, INC.
	SUBSTANTIALLY EQUIVALENT	1
DEEPLOOK INC.
	SUBSTANTIALLY EQUIVALENT	1
DEEPTEK MEDICAL IMAGING PRIVATE LIMITED
	SUBSTANTIALLY EQUIVALENT	1
DENSITAS, INC.
	SUBSTANTIALLY EQUIVALENT	1
DENTI.AI TECHNOLOGY INC.
	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
DISIOR LTD
	SUBSTANTIALLY EQUIVALENT	1
DOSISOFT SA
	SUBSTANTIALLY EQUIVALENT	1
DRTECH CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
DURR DENTAL SE
	SUBSTANTIALLY EQUIVALENT	1
DÜRR DENTAL SE
	SUBSTANTIALLY EQUIVALENT	1
DYAD MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
EBM TECHNOLOGIES INC.
	SUBSTANTIALLY EQUIVALENT	1
ECHOPIXEL, INC.
	SUBSTANTIALLY EQUIVALENT	1
ELUCID BIOIMAGING INC.
	SUBSTANTIALLY EQUIVALENT	1
ELUCID BIOIMAGING, INC.
	SUBSTANTIALLY EQUIVALENT	1
EOS IMAGING
	SUBSTANTIALLY EQUIVALENT	1
ERAD, INC.
	SUBSTANTIALLY EQUIVALENT	1
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	3
EWOOSOFT CO., LTD
	SUBSTANTIALLY EQUIVALENT	8
EWOOSOFT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	4
EXINI DIAGNOSTICS AB
	SUBSTANTIALLY EQUIVALENT	2
EXOCAD GMBH
	SUBSTANTIALLY EQUIVALENT	1
EZRA AI, INC.
	SUBSTANTIALLY EQUIVALENT	1
FH INDUSTRIE
	SUBSTANTIALLY EQUIVALENT	2
FOVIA, INC.
	SUBSTANTIALLY EQUIVALENT	1
FUJIFILM CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
FUJIFILM CORPORATON
	SUBSTANTIALLY EQUIVALENT	1
GALGO MEDICAL S.L
	SUBSTANTIALLY EQUIVALENT	1
GE HEALTHCARE
	SUBSTANTIALLY EQUIVALENT	3
GE HEALTHCARE GMBH
	SUBSTANTIALLY EQUIVALENT	1
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
	SUBSTANTIALLY EQUIVALENT	1
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 CARE DIAGNOSTICS
	SUBSTANTIALLY EQUIVALENT	1
HDX WILL CORP.
	SUBSTANTIALLY EQUIVALENT	1
HEURON CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3
HOTH INTELLIGENCE INC.
	SUBSTANTIALLY EQUIVALENT	1
HURA IMAGING, INC.
	SUBSTANTIALLY EQUIVALENT	1
HYPERFINE RESEARCH, INC
	SUBSTANTIALLY EQUIVALENT	1
IAID
	SUBSTANTIALLY EQUIVALENT	1
ICAT SOLUTIONS LTD
	SUBSTANTIALLY EQUIVALENT	2
ICOMETRIX NV
	SUBSTANTIALLY EQUIVALENT	1
IMAGE INSTRUMENTS GMBH
	SUBSTANTIALLY EQUIVALENT	1
IMAGING WAVE, LLC
	SUBSTANTIALLY EQUIVALENT	1
IMMERSIVETOUCH
	SUBSTANTIALLY EQUIVALENT	1
IMMERSIVETOUCH, INC.
	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
INTRADYS
	SUBSTANTIALLY EQUIVALENT	1
INVIVO CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
INVIZ CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
IONIC HEALTH
	SUBSTANTIALLY EQUIVALENT	1
IRM INC
	SUBSTANTIALLY EQUIVALENT	1
ISCHEMA VIEW INC.
	SUBSTANTIALLY EQUIVALENT	2
JAZZ IMAGING
	SUBSTANTIALLY EQUIVALENT	1
JLK, INC.
	SUBSTANTIALLY EQUIVALENT	3
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 INC.
	SUBSTANTIALLY EQUIVALENT	1
LG ELECTRONICS.INC
	SUBSTANTIALLY EQUIVALENT	1
LIMBUS AI INC.
	SUBSTANTIALLY EQUIVALENT	2
LONGWOOD VALLEY MEDICAL LTD
	SUBSTANTIALLY EQUIVALENT	1
MATERIALISE N.V.
	SUBSTANTIALLY EQUIVALENT	1
MATERIALISE NV
	SUBSTANTIALLY EQUIVALENT	2
MDAI INC
	SUBSTANTIALLY EQUIVALENT	1
MEDACTA INTERNATIONAL S.A.
	SUBSTANTIALLY EQUIVALENT	2
MEDACTA INTERNATIONAL SA
	SUBSTANTIALLY EQUIVALENT	3
MEDAPP S.A.
	SUBSTANTIALLY EQUIVALENT	1
MEDICAL TEMPLATES AG
	SUBSTANTIALLY EQUIVALENT	1
MEDICALCOMMUNICATIONS GMBH
	SUBSTANTIALLY EQUIVALENT	1
MEDICREA INTERNATIONAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDIIMG CORPORATION
	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
MEDVISO AB
	SUBSTANTIALLY EQUIVALENT	1
MEGAGEN IMPLANT CO. LTD
	SUBSTANTIALLY EQUIVALENT	1
MERGE HEALTHCARE INCORPORATED
	SUBSTANTIALLY EQUIVALENT	2
MICROSTRUCTURE IMAGING, INC.
	SUBSTANTIALLY EQUIVALENT	1
MIM SOFTWARE INC.
	SUBSTANTIALLY EQUIVALENT	5
MINT LABS, INC., D/B/A. QMENTA
	SUBSTANTIALLY EQUIVALENT	1
MIRADA MEDICAL LTD
	SUBSTANTIALLY EQUIVALENT	2
MIRRORME3D, LLC
	SUBSTANTIALLY EQUIVALENT	1
MOTILENT LTD
	SUBSTANTIALLY EQUIVALENT	1
MYCARDIUM AI LIMITED
	SUBSTANTIALLY EQUIVALENT	1
MYSEGMENTER TECHNOLOGIES INC.
	SUBSTANTIALLY EQUIVALENT	1
NAVBIT PTY LTD
	SUBSTANTIALLY EQUIVALENT	1
NAVIER MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
NAVISWISS AG
	SUBSTANTIALLY EQUIVALENT	1
NESA MEDTECH PRIVATE LIMITED
	SUBSTANTIALLY EQUIVALENT	1
NEUROPHET, INC.
	SUBSTANTIALLY EQUIVALENT	2
NEXSYS ELECTRONICS INC. DBA MEDWEB
	SUBSTANTIALLY EQUIVALENT	1
NICO-LAB B.V.
	SUBSTANTIALLY EQUIVALENT	1
NINES, INC.
	SUBSTANTIALLY EQUIVALENT	1
NOBEL BIOCARE AB
	SUBSTANTIALLY EQUIVALENT	4
NORDICNEUROLAB AS
	SUBSTANTIALLY EQUIVALENT	3
NUCLEUSHEALTH, 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
OPENRAD SERVICES UK LTD
	SUBSTANTIALLY EQUIVALENT	1
ORCA DENTAL AI LTD
	SUBSTANTIALLY EQUIVALENT	1
ORTHOFIX SRL
	SUBSTANTIALLY EQUIVALENT	1
ORTHOFIX US LLC
	SUBSTANTIALLY EQUIVALENT	1
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	1
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 LTD.
	SUBSTANTIALLY EQUIVALENT	1
PHANTOMICS INC.
	SUBSTANTIALLY EQUIVALENT	1
PHILIPS DS NORTH AMERICA LLC
	SUBSTANTIALLY EQUIVALENT	1
PHILIPS HEALTHCARE
	SUBSTANTIALLY EQUIVALENT	2
PHILIPS HEALTHCARE (SUZHOU) CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
	SUBSTANTIALLY EQUIVALENT	4
PHILIPS MEDICAL SYSTEMS TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	1
PHILIPS ULTRASOUND, INC
	SUBSTANTIALLY EQUIVALENT	1
PHILIPS ULTRASOUND, INC.
	SUBSTANTIALLY EQUIVALENT	2
PIE MEDICAL IMAGING B.V.
	SUBSTANTIALLY EQUIVALENT	2
PIXEE MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
PIXYL SA
	SUBSTANTIALLY EQUIVALENT	1
PLANMECA OY
	SUBSTANTIALLY EQUIVALENT	1
PMX INC.
	SUBSTANTIALLY EQUIVALENT	1
POLAREAN, INC.
	SUBSTANTIALLY EQUIVALENT	1
PRECISIONOS TECHNOLOGY INC.
	SUBSTANTIALLY EQUIVALENT	1
PRODIGIDENT, INC.
	SUBSTANTIALLY EQUIVALENT	1
PYMEDIX
	SUBSTANTIALLY EQUIVALENT	1
QUANTIB B.V.
	SUBSTANTIALLY EQUIVALENT	1
QUANTIB BV
	SUBSTANTIALLY EQUIVALENT	4
QUIBIM S.L.
	SUBSTANTIALLY EQUIVALENT	1
RADICAL IMAGING, LLC
	SUBSTANTIALLY EQUIVALENT	1
RADIOBOTICS APS
	SUBSTANTIALLY EQUIVALENT	1
RADISEN CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
RADLINK, INC.
	SUBSTANTIALLY EQUIVALENT	1
RADUNITY CORP.
	SUBSTANTIALLY EQUIVALENT	1
RAMSOFT INC.
	SUBSTANTIALLY EQUIVALENT	1
RAY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
REAL VIEW IMAGING LTD.
	SUBSTANTIALLY EQUIVALENT	1
REALIZE MEDICAL INC.
	SUBSTANTIALLY EQUIVALENT	1
RICOH USA, INC.
	SUBSTANTIALLY EQUIVALENT	2
ROCLUB GMBH
	SUBSTANTIALLY EQUIVALENT	1
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
SENTIAR, INC
	SUBSTANTIALLY EQUIVALENT	1
SENTIAR, INC.
	SUBSTANTIALLY EQUIVALENT	1
SERV MEDICAL PTE. LTD
	SUBSTANTIALLY EQUIVALENT	1
SHANGHAI UNITED IMAGING HEALTHCARE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	4
SIEMENS HEALTHCARE GMBH
	SUBSTANTIALLY EQUIVALENT	7
SIEMENS MEDICAL SOLUTION USA, INC.
	SUBSTANTIALLY EQUIVALENT	1
SIEMENS MEDICAL SOLUTIONS USA INC.
	SUBSTANTIALLY EQUIVALENT	2
SIEMENS MEDICAL SOLUTIONS USA, INC
	SUBSTANTIALLY EQUIVALENT	1
SIEMENS MEDICAL SOLUTIONS USA, INC.
	SUBSTANTIALLY EQUIVALENT	6
SIEMENS MEDICAL SOLUTIONS, USA, INC.
	SUBSTANTIALLY EQUIVALENT	1
SIEMENS MEDICAL SOULTIONS USA, INC.
	SUBSTANTIALLY EQUIVALENT	1
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	1
SOTA PRECISION OPTICS, INC. DBA SOTA IMAGING
	SUBSTANTIALLY EQUIVALENT	1
SPECTO MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
SPECTRUM DYNAMICS MEDICAL LTD
	SUBSTANTIALLY EQUIVALENT	1
SUBTLE MEDICAL INC.
	SUBSTANTIALLY EQUIVALENT	1
SUBTLE MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	3
SURGICAL INFORMATION SCIENCES, INC.
	SUBSTANTIALLY EQUIVALENT	1
SURGICAL THEATER, INC.
	SUBSTANTIALLY EQUIVALENT	1
SYNOPSYS (NORTHERN EUROPE) LTD.
	SUBSTANTIALLY EQUIVALENT	1
SYNTHESIS HEALTH INTELLIGENCE INC
	SUBSTANTIALLY EQUIVALENT	1
TAE YOUNG SOFT CO., 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
THE METHODIST HOSPITAL RESEARCH INSTITUTE D/B/A HOUSTON
	SUBSTANTIALLY EQUIVALENT	1
TOMTEC IMAGING SYSTEMS GMBH
	SUBSTANTIALLY EQUIVALENT	1
TRANSLATIONAL MRI, LLC
	SUBSTANTIALLY EQUIVALENT	1
TURING MEDICAL TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
VIRTUAL RADIOLOGIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
VISIBLE PATIENT, SAS
	SUBSTANTIALLY EQUIVALENT	1
VISUS HEALTH IT GMBH
	SUBSTANTIALLY EQUIVALENT	3
VOLPARA HEALTH TECHNOLOGIES LIMITED
	SUBSTANTIALLY EQUIVALENT	1
VOXIMETRY, INCORPORATED
	SUBSTANTIALLY EQUIVALENT	1
VUZE MEDICAL LTD.
	SUBSTANTIALLY EQUIVALENT	2
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
ZIOSOFT, INC.
	SUBSTANTIALLY EQUIVALENT	1
ZIRKONZAHN SRL
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2020	82	82
2021	70	70
2022	28	28
2023	26	26
2024	42	42
2025	28	28

Device Problems	MDRs with this Device Problem	Events in those MDRs
Computer Software Problem	79	79
Application Program Problem: Parameter Calculation Error	46	46
Loss of Data	32	32
Use of Device Problem	20	20
Improper or Incorrect Procedure or Method	19	19
Data Problem	13	13
Application Program Problem	12	12
Adverse Event Without Identified Device or Use Problem	12	12
Insufficient Information	11	11
Patient Data Problem	11	11
Use of Incorrect Control/Treatment Settings	11	11
No Apparent Adverse Event	6	6
Application Program Freezes, Becomes Nonfunctional	5	5
Image Display Error/Artifact	5	5
Incorrect Measurement	5	5
Inadequate User Interface	3	3
Device Displays Incorrect Message	3	3
No Display/Image	3	3
Output Problem	3	3
Defective Component	3	3
Incorrect, Inadequate or Imprecise Result or Readings	3	3
Missing Test Results	3	3
Display or Visual Feedback Problem	2	2
Inaccurate Information	2	2
Installation-Related Problem	2	2
Product Quality Problem	2	2
Calibration Problem	2	2
Failure to Back-Up	2	2
Unexpected Shutdown	2	2
Failure to Power Up	1	1
Battery Problem	1	1
Unable to Obtain Readings	1	1
Unintended Application Program Shut Down	1	1
Problem with Software Installation	1	1
High Readings	1	1
Labelling, Instructions for Use or Training Problem	1	1
Therapeutic or Diagnostic Output Failure	1	1
Failure to Transmit Record	1	1
Program or Algorithm Execution Failure	1	1
Wireless Communication Problem	1	1
Device Markings/Labelling Problem	1	1
Missing Information	1	1
No Visual Prompts/Feedback	1	1
Communication or Transmission Problem	1	1
Connection Problem	1	1
Mechanical Problem	1	1
Break	1	1
Reset Problem	1	1
Operating System Becomes Nonfunctional	1	1
Device Ingredient or Reagent Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	181	181
No Known Impact Or Consequence To Patient	33	33
Insufficient Information	15	15
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	14	14
No Consequences Or Impact To Patient	14	14
Breast Mass	11	11
Pneumonia	4	4
No Patient Involvement	3	3
Pneumothorax	2	2
Unintended Radiation Exposure	2	2
Bacterial Infection	2	2
Hematoma	2	2
Hemorrhage/Bleeding	2	2
Cardiac Arrest	2	2
Thrombosis/Thrombus	2	2
Unspecified Heart Problem	2	2
Ruptured Aneurysm	2	2
Unspecified Tissue Injury	2	2
Unspecified Reproductive System or Breast Problem	1	1
Device Embedded In Tissue or Plaque	1	1
Ambulation Difficulties	1	1
Tissue Breakdown	1	1
Cancer	1	1
Myocardial Infarction	1	1
Endocarditis	1	1
Radiation Overdose	1	1
Cough	1	1
Missing Value Reason	1	1
Scar Tissue	1	1
Dyspnea	1	1
Pain	1	1
Radiation Underdose	1	1
Erythema	1	1
Chest Pain	1	1
Viral Infection	1	1
Pleural Effusion	1	1
Burning Sensation	1	1
Foreign Body In Patient	1	1
Blister	1	1
Ischemic Heart Disease	1	1
Cyst(s)	1	1
Hemoptysis	1	1
Misdiagnosis	1	1
Gastrointestinal Hemorrhage	1	1
Fatigue	1	1
Brain Injury	1	1
Death	1	1
Patient Problem/Medical Problem	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Agfa Healthcare NV	II	Oct-10-2024
2	Agfa Healthcare NV	II	Jan-20-2023
3	Brainlab AG	II	Mar-18-2025
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	Echopixel, Inc.	II	May-21-2025
13	Echopixel, Inc.	II	May-16-2025
14	Exocad GmbH	II	Sep-25-2023
15	FUJIFILM Healthcare Americas Corporation	II	Mar-20-2025
16	FUJIFILM Healthcare Americas Corporation	II	Mar-07-2024
17	FUJIFILM Healthcare Americas Corporation	II	Feb-21-2024
18	Fujifilm Medical Systems U.S.A., Inc.	II	Jun-02-2021
19	Fujifilm Medical Systems U.S.A., Inc.	II	Apr-02-2021
20	Fujifilm Medical Systems U.S.A., Inc.	II	Jan-22-2021
21	Fujifilm Medical Systems U.S.A., Inc.	II	Jan-17-2021
22	Fujifilm Medical Systems U.S.A., Inc.	II	Oct-22-2020
23	Fujifilm Medical Systems U.S.A., Inc.	II	Jun-30-2020
24	GE Healthcare	II	Mar-28-2025
25	GE Healthcare	II	Nov-07-2024
26	GE Healthcare	II	Oct-09-2024
27	GE Healthcare	II	Sep-24-2024
28	GE Healthcare	II	Sep-17-2024
29	GE Healthcare	II	Oct-23-2023
30	GE Healthcare	II	Oct-20-2023
31	GE Healthcare	II	May-02-2023
32	GE Healthcare GmbH	II	Sep-13-2024
33	GE Healthcare, LLC	II	Aug-24-2022
34	GE Healthcare, LLC	II	Jul-25-2022
35	GE Healthcare, LLC	II	Jul-05-2022
36	GE Healthcare, LLC	II	Jun-03-2022
37	GE Healthcare, LLC	II	Dec-02-2021
38	GE Healthcare, LLC	II	Oct-02-2021
39	GE Healthcare, LLC	II	Sep-22-2021
40	GE Healthcare, LLC	II	May-05-2021
41	GE Healthcare, LLC	II	Jan-17-2020
42	GE Medical Systems, LLC	II	Dec-16-2022
43	INTELERAD MEDICAL SYSTEMS INCORPORATED	II	Feb-21-2025
44	Immersivetouch Inc	III	May-18-2020
45	Koios Medical, Inc.	II	Jan-17-2020
46	Konica Minolta Healthcare Americas, Inc.	II	Jan-14-2022
47	MIM Software Inc	II	Mar-04-2025
48	Medicrea International	II	Feb-07-2025
49	Merge Healthcare, Inc.	II	Mar-20-2025
50	Merge Healthcare, Inc.	II	Sep-09-2020
51	Merge Healthcare, Inc.	II	Jun-19-2020
52	Mint Medical GmbH	II	Dec-20-2024
53	NordicNeuroLab AS	II	Jul-25-2022
54	Novarad Corporation	II	Sep-12-2020
55	OLEA MEDICAL	II	Oct-18-2023
56	Philips Healthcare Informatics, Inc.	II	Jun-10-2020
57	Philips Medical Systems Nederland B.V.	II	May-08-2025
58	Philips Medical Systems Nederland B.V.	II	Feb-28-2025
59	Philips Medical Systems Technologies Ltd.	II	Nov-20-2024
60	Philips North America, LLC	II	Jan-13-2021
61	Philips North America Llc	II	Apr-06-2022
62	SICAT GMBH & CO. KG	II	Sep-10-2020
63	Simpleware Product Group, SYNOPSYS NORTHERN EUROPE	II	Aug-12-2021
64	Synaptive Medical Inc	II	Apr-22-2020
65	Tomtec Imaging Systems Gmbh	II	Jul-04-2020
66	Virtual Radiologic Corp.	II	Jul-21-2023