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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device system, image processing, radiological
Product CodeLLZ
Regulation Number 892.2050
Device Class 2


Premarket Reviews
ManufacturerDecision
3D INDUSTRIAL IMAGING CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
3D ONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
3D SYSTEMS, 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
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
ANGIOCLOUD, LLC
  SUBSTANTIALLY EQUIVALENT 1
APOLLO MEDICAL IMAGING TECHNOLOGY PTY. LTD.
  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
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
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 3
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
CERCARE MEDICAL A/S
  SUBSTANTIALLY EQUIVALENT 1
CERCARE MEDICAL APS
  SUBSTANTIALLY EQUIVALENT 1
CERTIS HEALTH
  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 3
CLARITAS HEALTHTECH PTE LTD
  SUBSTANTIALLY EQUIVALENT 2
CLARUS VIEWER CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
CLEERLY INC
  SUBSTANTIALLY EQUIVALENT 1
CLEERLY, INC.
  SUBSTANTIALLY EQUIVALENT 1
CONVERGENT IMAGING SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
CORELINE SOFT CO., LTD
  SUBSTANTIALLY EQUIVALENT 3
CORELINE SOFT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CORIN USA
  SUBSTANTIALLY EQUIVALENT 3
CORTICOMETRICS LLC
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN LLC.
  SUBSTANTIALLY EQUIVALENT 1
CUPTIMIZE, INC.
  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 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 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
ELUCID BIOIMAGING INC.
  SUBSTANTIALLY EQUIVALENT 1
EOS IMAGING
  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 4
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
FUJIFILM CORPORATION
  SUBSTANTIALLY EQUIVALENT 5
FUJIFILM CORPORATON
  SUBSTANTIALLY EQUIVALENT 1
GALGO MEDICAL S.L
  SUBSTANTIALLY EQUIVALENT 1
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 3
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
HERMES MEDICAL SOLUTIONS AB
  SUBSTANTIALLY EQUIVALENT 1
HEURON CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
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
ICAT SOLUTIONS LTD
  SUBSTANTIALLY EQUIVALENT 1
ICOMETRIX NV
  SUBSTANTIALLY EQUIVALENT 2
IMAGE INSTRUMENTS GMBH
  SUBSTANTIALLY EQUIVALENT 1
IMAGING BIOMETRICS, LLC
  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
INTUITIVE SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
INVIVO CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
INVIZ CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
IONIC HEALTH
  SUBSTANTIALLY EQUIVALENT 1
IRM INC
  SUBSTANTIALLY EQUIVALENT 1
ISCHEMA VIEW 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 3
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 2
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
MEDICAD HECTEC GMBH
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL TEMPLATES AG
  SUBSTANTIALLY EQUIVALENT 1
MEDICALCOMMUNICATIONS GMBH
  SUBSTANTIALLY EQUIVALENT 1
MEDICALIP CO., LTD
  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 3
MIM SOFTWARE INC.
  SUBSTANTIALLY EQUIVALENT 4
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
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 4
NORDICNEUROLAB AS
  SUBSTANTIALLY EQUIVALENT 1
NUCLEUSHEALTH, LLC
  SUBSTANTIALLY EQUIVALENT 1
NUVASIVE, INCORPORATED
  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
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 1
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 MEDICAL SYSTEMS NEDERLAND B.V.
  SUBSTANTIALLY EQUIVALENT 3
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
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 4
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
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
SICAT GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE GMBH
  SUBSTANTIALLY EQUIVALENT 7
SIEMENS MEDICAL SOLUTION USA, INC.
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS MEDICAL SOLUTIONS USA INC.
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS MEDICAL SOLUTIONS USA, INC.
  SUBSTANTIALLY EQUIVALENT 8
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
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
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
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
VENTRIPOINT DIAGNOSTICS, LTD.
  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
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 80 80
Computer Software Problem 77 77
Use of Device Problem 69 69
Application Program Problem: Parameter Calculation Error 29 29
Adverse Event Without Identified Device or Use Problem 25 25
Data Problem 20 20
Patient Data Problem 15 15
Application Program Problem 10 10
Improper or Incorrect Procedure or Method 9 9
No Apparent Adverse Event 7 7
Insufficient Information 7 7
Data Back-Up Problem 6 6
Image Display Error/Artifact 5 5
Application Program Freezes, Becomes Nonfunctional 5 5
Missing Test Results 3 3
No Display/Image 3 3
Incorrect, Inadequate or Imprecise Result or Readings 3 3
Inadequate User Interface 3 3
Output Problem 3 3
Defective Component 3 3
Communication or Transmission Problem 2 2
Failure to Back-Up 2 2
Display or Visual Feedback Problem 2 2
Incorrect Measurement 2 2
Unexpected Shutdown 2 2
No Visual Prompts/Feedback 1 1
Unintended Application Program Shut Down 1 1
Program or Algorithm Execution Failure 1 1
Wireless Communication Problem 1 1
Operating System Becomes Nonfunctional 1 1
Mechanical Problem 1 1
Poor Quality Image 1 1
Electrical /Electronic Property Problem 1 1
Break 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
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
Device Displays Incorrect Message 1 1
Problem with Software Installation 1 1
Reset Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Device Ingredient or Reagent Problem 1 1
Electrical Power Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 143 143
No Known Impact Or Consequence To Patient 85 85
No Consequences Or Impact To Patient 45 45
Insufficient Information 8 8
No Patient Involvement 4 4
Misdiagnosis 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Unintended Radiation Exposure 2 2
Ruptured Aneurysm 2 2
Thrombosis/Thrombus 2 2
Bacterial Infection 2 2
Pneumonia 2 2
Pneumothorax 2 2
Death 2 2
Dyspnea 1 1
Endocarditis 1 1
Hematoma 1 1
Hemoptysis 1 1
Hemorrhage/Bleeding 1 1
Pain 1 1
Pleural Effusion 1 1
Scar Tissue 1 1
Chest Pain 1 1
Cyst(s) 1 1
Brain Injury 1 1
Viral Infection 1 1
Ambulation Difficulties 1 1
Vascular System (Circulation), Impaired 1 1
Unspecified Heart Problem 1 1
Cough 1 1
Unspecified Tissue Injury 1 1
Radiation Overdose 1 1
Radiation Underdose 1 1
Foreign Body In Patient 1 1
Patient Problem/Medical Problem 1 1
Device Embedded In Tissue or Plaque 1 1
No Code Available 1 1
Missing Value Reason 1 1
Cancer 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Agfa Healthcare NV II Jan-20-2023
2 Brainreader ApS II Jan-29-2021
3 CHANGE HEALTHCARE CANADA COMPANY II Dec-14-2023
4 CHANGE HEALTHCARE CANADA COMPANY II Nov-06-2023
5 CHANGE HEALTHCARE CANADA COMPANY II Jun-02-2021
6 CHANGE HEALTHCARE CANADA COMPANY II Apr-28-2021
7 CHANGE HEALTHCARE CANADA COMPANY II Oct-08-2020
8 DICOM Grid, Inc. d/b/a Ambra Health II Sep-27-2022
9 Digisonics, Inc II Jul-20-2023
10 Exocad GmbH II Sep-25-2023
11 FUJIFILM Healthcare Americas Corporation II Mar-07-2024
12 FUJIFILM Healthcare Americas Corporation II Feb-21-2024
13 Fujifilm Medical Systems U.S.A., Inc. II Jun-02-2021
14 Fujifilm Medical Systems U.S.A., Inc. II Apr-02-2021
15 Fujifilm Medical Systems U.S.A., Inc. II Jan-22-2021
16 Fujifilm Medical Systems U.S.A., Inc. II Jan-17-2021
17 Fujifilm Medical Systems U.S.A., Inc. II Oct-22-2020
18 Fujifilm Medical Systems U.S.A., Inc. II Jun-30-2020
19 GE Healthcare II Oct-23-2023
20 GE Healthcare II Oct-20-2023
21 GE Healthcare II May-02-2023
22 GE Healthcare, LLC II Aug-24-2022
23 GE Healthcare, LLC II Jul-25-2022
24 GE Healthcare, LLC II Jul-05-2022
25 GE Healthcare, LLC II Jun-03-2022
26 GE Healthcare, LLC II Dec-02-2021
27 GE Healthcare, LLC II Oct-02-2021
28 GE Healthcare, LLC II Sep-22-2021
29 GE Healthcare, LLC II May-05-2021
30 GE Healthcare, LLC II Jan-17-2020
31 GE Healthcare, LLC II Jul-01-2019
32 GE Healthcare, LLC II Jun-26-2019
33 GE Healthcare, LLC II Jun-13-2019
34 GE Healthcare, LLC II Feb-01-2019
35 GE Medical Systems, LLC II Dec-16-2022
36 Immersivetouch Inc III May-18-2020
37 Koios Medical, Inc. II Jan-17-2020
38 Konica Minolta Healthcare Americas, Inc. II Jan-14-2022
39 Merge Healthcare, Inc. II Sep-09-2020
40 Merge Healthcare, Inc. II Jun-19-2020
41 Merge Healthcare, Inc. II Jul-23-2019
42 NordicNeuroLab AS II Jul-25-2022
43 Novarad Corporation II Sep-12-2020
44 OLEA MEDICAL II Oct-18-2023
45 Philips Healthcare Informatics, Inc. II Jun-10-2020
46 Philips North America, LLC II Jan-13-2021
47 Philips North America Llc II Apr-06-2022
48 SICAT GMBH & CO. KG II Sep-10-2020
49 Simpleware Product Group, SYNOPSYS NORTHERN EUROPE II Aug-12-2021
50 Synaptive Medical Inc II Apr-22-2020
51 Tomtec Imaging Systems Gmbh II Jul-04-2020
52 Virtual Radiologic Corp. II Jul-21-2023
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