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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
Regulation Description Picture archiving and communications system.
Product CodeLLZ
Regulation Number 892.2050
Device Class 2


Premarket Reviews
ManufacturerDecision
3D INDUSTRIAL IMAGING CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
3D INDUSTRIAL IMAGING CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
3D INDUSTRIAL IMAGING CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
3D SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
3DIEMME LTD.
  SUBSTANTIALLY EQUIVALENT 1
3DSYSTEMS, SIMBIONIX PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
3SHAPE MEDICAL A/S
  SUBSTANTIALLY EQUIVALENT 1
4QIMAGING, LLC DBA QMETRICS
  SUBSTANTIALLY EQUIVALENT 1
ACROVIZ INC.
  SUBSTANTIALLY EQUIVALENT 1
ADAS3D MEDICAL S.L
  SUBSTANTIALLY EQUIVALENT 2
ADM DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
AGFA HEALTHCARE N.V.
  SUBSTANTIALLY EQUIVALENT 2
AI METRICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
AIQ SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ALGOMEDICA
  SUBSTANTIALLY EQUIVALENT 1
ALTARAVISION INC.
  SUBSTANTIALLY EQUIVALENT 1
AMCAD BIOMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
ANATOMAGE INC.
  SUBSTANTIALLY EQUIVALENT 1
ANATOMAGE, INC
  SUBSTANTIALLY EQUIVALENT 1
APOLLO MEDICAL IMAGING TECHNOLOGY PTY. LTD.
  SUBSTANTIALLY EQUIVALENT 1
APTERYX, INC.
  SUBSTANTIALLY EQUIVALENT 1
ARTERYS INC.
  SUBSTANTIALLY EQUIVALENT 5
ARTHREX INC.
  SUBSTANTIALLY EQUIVALENT 1
ASCEND HIT
  SUBSTANTIALLY EQUIVALENT 1
BAY LABS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOBOT SURGICAL PTE LTD
  SUBSTANTIALLY EQUIVALENT 1
BIOMET INC.
  SUBSTANTIALLY EQUIVALENT 1
BODY VISION MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 2
BRAID.HEALTH
  SUBSTANTIALLY EQUIVALENT 1
BRAINLAB AG
  SUBSTANTIALLY EQUIVALENT 4
BRAINNOW MEDICAL TECHNOLOGY LIMITED
  SUBSTANTIALLY EQUIVALENT 1
BRAINOMIX LIMITED
  SUBSTANTIALLY EQUIVALENT 1
CALGARY SCIENTIFIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
CANON MEDICAL SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 5
CARDIOWISE, INC.
  SUBSTANTIALLY EQUIVALENT 1
CARESTREAM HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 2
CARISTO DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1
CEEVRA, INC.
  SUBSTANTIALLY EQUIVALENT 2
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 1
CIRCLE CARDIOVASCULAR IMAGING INC.
  SUBSTANTIALLY EQUIVALENT 1
CLARIPI INC.
  SUBSTANTIALLY EQUIVALENT 2
CLEARVIEW DIAGNOSTICS INC.
  SUBSTANTIALLY EQUIVALENT 1
CLEERLY INC
  SUBSTANTIALLY EQUIVALENT 1
CLEERLY, INC.
  SUBSTANTIALLY EQUIVALENT 1
CLIENT OUTLOOK INC.
  SUBSTANTIALLY EQUIVALENT 2
COMBINOSTICS OY
  SUBSTANTIALLY EQUIVALENT 1
COMPANIA MEXICANA DE RADIOLOGIA CGR, S.A. DE C.V.
  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
CORTECHS LABS, INC
  SUBSTANTIALLY EQUIVALENT 1
CORTICOMETRICS LLC
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN LLC.
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN, LLC
  SUBSTANTIALLY EQUIVALENT 1
CUPTIMIZE, INC.
  SUBSTANTIALLY EQUIVALENT 1
CURVE DENTAL LTD
  SUBSTANTIALLY EQUIVALENT 1
CURVEBEAM, LLC
  SUBSTANTIALLY EQUIVALENT 1
CUSTOM ORTHOPAEDIC SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
DALIAN SENYINT DIGITAL MEDICAL SYSTEM CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DE GOTZEN S.R.L
  SUBSTANTIALLY EQUIVALENT 1
DEEPLOOK INC.
  SUBSTANTIALLY EQUIVALENT 1
DENSITAS, INC.
  SUBSTANTIALLY EQUIVALENT 2
DENTSPLY SIRONA
  SUBSTANTIALLY EQUIVALENT 3
DIACARDIO, LTD.
  SUBSTANTIALLY EQUIVALENT 1
DICOM GRID, INC, DBA AMBRA HEALTH
  SUBSTANTIALLY EQUIVALENT 1
DICOM GRID, INC.
  SUBSTANTIALLY EQUIVALENT 1
DIGITALCORE CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
DISIOR LTD
  SUBSTANTIALLY EQUIVALENT 1
DOSISOFT
  SUBSTANTIALLY EQUIVALENT 1
DRGEM CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
DUERR DENTAL AG
  SUBSTANTIALLY EQUIVALENT 1
DURR DENTAL AG
  SUBSTANTIALLY EQUIVALENT 1
DURR DENTAL SE
  SUBSTANTIALLY EQUIVALENT 2
DÜRR DENTAL SE
  SUBSTANTIALLY EQUIVALENT 1
EBIT SRL
  SUBSTANTIALLY EQUIVALENT 1
EBM TECHNOLOGIES INC.
  SUBSTANTIALLY EQUIVALENT 1
EBM TECHNOLOGIES INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
EC-WEB CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ECHOPIXEL INC.
  SUBSTANTIALLY EQUIVALENT 2
ECHOPIXEL, INC.
  SUBSTANTIALLY EQUIVALENT 1
EIGEN
  SUBSTANTIALLY EQUIVALENT 2
ELUCID BIOIMAGING INC.
  SUBSTANTIALLY EQUIVALENT 1
ELUCID BIOIMAGING, INC.
  SUBSTANTIALLY EQUIVALENT 1
EOS IMAGING
  SUBSTANTIALLY EQUIVALENT 1
EOS IMAGING, INC.
  SUBSTANTIALLY EQUIVALENT 1
EVER FORTUNE.AI CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
EVOLVE PACS INC.
  SUBSTANTIALLY EQUIVALENT 1
EWOO SOFT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 12
EWOOSOFT CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
EWOOSOFT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
EXAMION GMBH
  SUBSTANTIALLY EQUIVALENT 1
EXINI DIAGNOSTICS AB
  SUBSTANTIALLY EQUIVALENT 2
EXOCAD GMBH
  SUBSTANTIALLY EQUIVALENT 1
FH INDUSTRIE
  SUBSTANTIALLY EQUIVALENT 1
FOCAL HEALTCARE INC.
  SUBSTANTIALLY EQUIVALENT 1
FOCAL HEALTHCARE INC.
  SUBSTANTIALLY EQUIVALENT 1
FUJIFILM CORPORATION
  SUBSTANTIALLY EQUIVALENT 5
FUJIFILM CORPORATON
  SUBSTANTIALLY EQUIVALENT 1
FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
  SUBSTANTIALLY EQUIVALENT 4
GALGO MEDICAL S.L
  SUBSTANTIALLY EQUIVALENT 1
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 6
GE MEDICAL SYSTEMS SCS
  SUBSTANTIALLY EQUIVALENT 3
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 3
GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIAGNOSTICS,
  SUBSTANTIALLY EQUIVALENT 1
GE MEDICAL SYSTEMS, SCS
  SUBSTANTIALLY EQUIVALENT 1
HARMONUS INC.
  SUBSTANTIALLY EQUIVALENT 1
HDX WILL CORP.
  SUBSTANTIALLY EQUIVALENT 2
HEALTHMYNE, INC
  SUBSTANTIALLY EQUIVALENT 1
HEART IMAGING TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
HEPATIQ LLC
  SUBSTANTIALLY EQUIVALENT 1
HERMES MEDICAL SOLUTIONS AB
  SUBSTANTIALLY EQUIVALENT 1
HEURON CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HINACOM SOFTWARE AND TECHNOLOGY, LTD
  SUBSTANTIALLY EQUIVALENT 1
HOLOGIC, INC.
  SUBSTANTIALLY EQUIVALENT 2
HYPERFINE RESEARCH, INC
  SUBSTANTIALLY EQUIVALENT 1
IB LAB GMBH
  SUBSTANTIALLY EQUIVALENT 1
ICAD, INC
  SUBSTANTIALLY EQUIVALENT 1
ICOMETRIX
  SUBSTANTIALLY EQUIVALENT 2
ICOMETRIX NV
  SUBSTANTIALLY EQUIVALENT 3
IGI TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
IMAGE ANALYSIS LIMITED
  SUBSTANTIALLY EQUIVALENT 1
IMAGING BIOMETRICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
IMBIO, LLC
  SUBSTANTIALLY EQUIVALENT 1
IMPLANTER LLC
  SUBSTANTIALLY EQUIVALENT 1
INFINITT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
INFINITT HEALTHCARE CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 3
INTELERAD MEDICAL SYSTEMS INCORPORATED
  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
IRM INC
  SUBSTANTIALLY EQUIVALENT 1
ISCHEMAVIEW, INC.
  SUBSTANTIALLY EQUIVALENT 2
JOINTPOINT, INC.
  SUBSTANTIALLY EQUIVALENT 1
JOINTVUE LLC
  SUBSTANTIALLY EQUIVALENT 3
JPI HEALTHCARE SOLUTIONS, INC
  SUBSTANTIALLY EQUIVALENT 1
KEOSYS SAS
  SUBSTANTIALLY EQUIVALENT 1
KICO KNEE INNOVATION COMPANY PTY LIMITED
  SUBSTANTIALLY EQUIVALENT 1
KINEPICT HEALTH LTD
  SUBSTANTIALLY EQUIVALENT 2
KONICA MINOLTA, INC.
  SUBSTANTIALLY EQUIVALENT 3
LAZARUS, 3D, INC
  SUBSTANTIALLY EQUIVALENT 1
LENTO MEDICAL INNOVATION, INC.
  SUBSTANTIALLY EQUIVALENT 1
LEXI CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
LG ELECTRONICS
  SUBSTANTIALLY EQUIVALENT 1
LIFETRACK MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
LIMBUS AI INC.
  SUBSTANTIALLY EQUIVALENT 1
MATAKINA TECHNOLOGY LTD
  SUBSTANTIALLY EQUIVALENT 1
MATERIALISE N.V.
  SUBSTANTIALLY EQUIVALENT 1
MATERIALISE NV
  SUBSTANTIALLY EQUIVALENT 3
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 3
MEDCOM GMBH
  SUBSTANTIALLY EQUIVALENT 2
MEDDIFF TECHNOLOGIES PVT. LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDIA LAB S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
MEDIC VISION - IMAGING SOLUTIONS LTD
  SUBSTANTIALLY EQUIVALENT 1
MEDICAD HECTEC GMBH
  SUBSTANTIALLY EQUIVALENT 2
MEDICALCOMMUNICATIONS GMBH
  SUBSTANTIALLY EQUIVALENT 1
MEDICALIP CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
MEDICREA INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 2
MEDIVIS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDSYNAPTIC PRIVATE LTD
  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
MERGE HEALTHCARE INCORPORATED
  SUBSTANTIALLY EQUIVALENT 5
MERIDIAN TECHNIQUE LTD
  SUBSTANTIALLY EQUIVALENT 1
MICROSOFT CORP.
  SUBSTANTIALLY EQUIVALENT 1
MIM SOFTWARE INC.
  SUBSTANTIALLY EQUIVALENT 5
MINT LABS, INC., D/B/A. QMENTA
  SUBSTANTIALLY EQUIVALENT 1
MIRADA MEDICAL LTD
  SUBSTANTIALLY EQUIVALENT 1
MIRADA MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
MULTIFUNCTIONAL IMAGING, LLC
  SUBSTANTIALLY EQUIVALENT 1
MULTIMODAL IMAGING SERVICES CORPORATION (DBA HEALTHLYTIX)
  SUBSTANTIALLY EQUIVALENT 1
NINES, INC.
  SUBSTANTIALLY EQUIVALENT 1
NOBEL BIOCARE AB
  SUBSTANTIALLY EQUIVALENT 5
NORDICNEUROLAB AS
  SUBSTANTIALLY EQUIVALENT 1
NOVARAD CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
NUCLEUSHEALTH, LLC
  SUBSTANTIALLY EQUIVALENT 2
NUVASIVE, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 2
O.N. DIAGNOSTICS, LLC.
  SUBSTANTIALLY EQUIVALENT 1
O3 ENTERPRISE SRL
  SUBSTANTIALLY EQUIVALENT 1
OLEA MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
OMNISCIENT NEUROTECHNOLOGY PTY LTD (O8T)
  SUBSTANTIALLY EQUIVALENT 1
ONEFIT MEDICAL
  SUBSTANTIALLY EQUIVALENT 4
ONEPACS, LLC
  SUBSTANTIALLY EQUIVALENT 1
OPTIMA HEALTH SOLUTIONS INTERNATIONAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
ORPHEUS MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
ORTHO KINEMATICS, INC
  SUBSTANTIALLY EQUIVALENT 1
ORTHO KINEMATICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
ORTHO2, LLC
  SUBSTANTIALLY EQUIVALENT 1
ORTHOFIX SRL
  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
OSKO, INC.
  SUBSTANTIALLY EQUIVALENT 1
OVERJET, INC.
  SUBSTANTIALLY EQUIVALENT 1
PALODEX GROUP OY
  SUBSTANTIALLY EQUIVALENT 1
PEEK HEALTH, S.A.
  SUBSTANTIALLY EQUIVALENT 1
PERSPECTUM DIAGNOSTICS LTD
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 4
PHILIPS HEALTHCARE INFORMATICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
  SUBSTANTIALLY EQUIVALENT 6
PHILIPS MEDICAL SYSTEMS NEDERLAND BV
  SUBSTANTIALLY EQUIVALENT 2
PHILIPS MEDICAL SYSTEMS NEDERLANDS B.V.
  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 1
PICOFEMTO LLC
  SUBSTANTIALLY EQUIVALENT 1
PIE MEDICAL IMAGING B.V.
  SUBSTANTIALLY EQUIVALENT 3
PIE MEDICAL IMAGING BV
  SUBSTANTIALLY EQUIVALENT 1
PLANMECA OY
  SUBSTANTIALLY EQUIVALENT 2
PLUM MEDICAL SOLUTIONS GMBH
  SUBSTANTIALLY EQUIVALENT 1
PROKNOW LLC
  SUBSTANTIALLY EQUIVALENT 1
PSP CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
QLARITY IMAGING
  SUBSTANTIALLY EQUIVALENT 1
QUANTIB BV
  SUBSTANTIALLY EQUIVALENT 6
QUANTITATIVE INSIGHTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
QUIBIM S.L.
  SUBSTANTIALLY EQUIVALENT 1
QYNAPSE
  SUBSTANTIALLY EQUIVALENT 1
RADIOBOTICS APS
  SUBSTANTIALLY EQUIVALENT 1
RAYENCE CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
RAYENCE CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
REAL VIEW IMAGING LTD.
  SUBSTANTIALLY EQUIVALENT 1
RESOUNDANT INC
  SUBSTANTIALLY EQUIVALENT 1
SAMSUNG MEDISON CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SATURN IMAGING INC.
  SUBSTANTIALLY EQUIVALENT 1
SEE-MODE TECHNOLOGIES PTE. LTD.
  SUBSTANTIALLY EQUIVALENT 1
SEGANA, LLC
  SUBSTANTIALLY EQUIVALENT 1
SENTIAR, INC
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI UNITED IMAGING HEALTHCARE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
SHANGHAI UNITED IMAGING HEALTHCARE CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 3
SICAT GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS HEALTHCARE GMBH
  SUBSTANTIALLY EQUIVALENT 7
SIEMENS MEDICAL SOLUTION USA, INC.
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS MEDICAL SOLUTIONS USA INC.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS MEDICAL SOLUTIONS USA, INC
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS MEDICAL SOLUTIONS USA, INC.
  SUBSTANTIALLY EQUIVALENT 14
SIEMENS MEDICAL SOLUTIONS, INC
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS MEDICAL SOLUTIONS, USA INC.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS MEDICAL SOLUTIONS, USA, INC.
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS MEDICAL SOULTIONS USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
SMARTTARGET, LTD.
  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 2
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1
SUBTLE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
SURGICAL INFORMATION SCIENCES, INC.
  SUBSTANTIALLY EQUIVALENT 4
SURGICAL THEATER, INC.
  SUBSTANTIALLY EQUIVALENT 1
SURGICAL THEATER, LLC
  SUBSTANTIALLY EQUIVALENT 2
SYNAPTIVE MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 2
SYNOPSYS (NORTHERN EUROPE) LTD.
  SUBSTANTIALLY EQUIVALENT 1
TAIHAO MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 2
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
THERENVA SAS
  SUBSTANTIALLY EQUIVALENT 1
TOMTEC IMAGING SYSTEMS GMBH
  SUBSTANTIALLY EQUIVALENT 1
TOSHIBA MEDICAL SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
TROPHY
  SUBSTANTIALLY EQUIVALENT 1
UC-CARE LTD.
  SUBSTANTIALLY EQUIVALENT 2
VARIAN MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
VENTRIPOINT DIAGNOSTICS, LTD.
  SUBSTANTIALLY EQUIVALENT 1
VIEWORKS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
VIRTUAL RADIOLOGIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
VISUS HEALTH IT GMBH
  SUBSTANTIALLY EQUIVALENT 2
VISUS TECHNOLOGY TRANSFER GMBH
  SUBSTANTIALLY EQUIVALENT 1
VITAL IMAGES, INC
  SUBSTANTIALLY EQUIVALENT 1
VITAL IMAGES, INC.
  SUBSTANTIALLY EQUIVALENT 6
VIZ.AI, INC.
  SUBSTANTIALLY EQUIVALENT 1
VOLPARA HEALTH TECHNOLOGIES LIMITED
  SUBSTANTIALLY EQUIVALENT 2
VOYANT HEALTH LTD
  SUBSTANTIALLY EQUIVALENT 1
XIAN WINGSPAN ELECTRONIC TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
XORAN TECHNOLOGIES LLC
  SUBSTANTIALLY EQUIVALENT 1
ZEBRA MEDICAL VISION LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZED TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
ZEPMED, LLC.
  SUBSTANTIALLY EQUIVALENT 1
ZETTA MEDICAL TECHNOLOGIES, LLC.
  SUBSTANTIALLY EQUIVALENT 2
ZIOSOFT, INC.
  SUBSTANTIALLY EQUIVALENT 2
ZIRKONZAHN SRL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 290 290
2017 104 104
2018 72 72
2019 88 88
2020 82 82
2021 56 56

Device Problems MDRs with this Device Problem Events in those MDRs
Computer Software Problem 191 191
Loss of Data 147 147
Data Problem 108 108
Use of Device Problem 76 76
Patient Data Problem 52 52
Device Operates Differently Than Expected 47 47
Device Issue 37 37
Adverse Event Without Identified Device or Use Problem 27 27
Application Program Problem: Parameter Calculation Error 22 22
Device Operational Issue 18 18
Application Program Problem 16 16
Improper or Incorrect Procedure or Method 14 14
Overheating of Device 10 10
Smoking 9 9
Incorrect Measurement 8 8
Computer Operating System Problem 7 7
Data Back-Up Problem 7 7
Application Interface Becomes Non-Functional Or Program Exits Abnormally 7 7
Image Display Error/Artifact 6 6
Device Displays Incorrect Message 6 6
Device Inoperable 5 5
Image Orientation Incorrect 5 5
Incorrect, Inadequate or Imprecise Resultor Readings 5 5
Display or Visual Feedback Problem 5 5
Output Problem 5 5
Programming Issue 5 5
Insufficient Information 5 5
No Apparent Adverse Event 4 4
Patient-Device Incompatibility 4 4
Communication or Transmission Problem 4 4
Poor Quality Image 4 4
Positioning Problem 4 4
Fitting Problem 3 3
Improper Device Output 3 3
Nonstandard Device 3 3
No Display/Image 3 3
Missing Test Results 3 3
Problem with Software Installation 2 2
Break 2 2
Failure to Power Up 2 2
Incorrect Software Programming Calculations 2 2
Structural Problem 2 2
Human Factors Issue 2 2
Battery Problem 2 2
Device Stops Intermittently 2 2
Display Difficult to Read 2 2
Failure to Back-Up 2 2
Failure to Read Input Signal 2 2
Inadequacy of Device Shape and/or Size 1 1
Failure to Convert to Back-Up 1 1
Unable to Obtain Readings 1 1
Failure to Transmit Record 1 1
Material Rupture 1 1
Self-Activation or Keying 1 1
Erratic or Intermittent Display 1 1
Electrical /Electronic Property Problem 1 1
Image Resolution Poor 1 1
Kinked 1 1
Unstable 1 1
Malposition of Device 1 1
Compatibility Problem 1 1
Material Deformation 1 1
Electrical Power Problem 1 1
Electrical Shorting 1 1
Facilities Issue 1 1
Reset Problem 1 1
No Visual Prompts/Feedback 1 1
Application Program Freezes, Becomes Nonfunctional 1 1
Human-Device Interface Problem 1 1
Inadequate User Interface 1 1
Installation-Related Problem 1 1
Measurement System Incompatibility 1 1
Application Program Version or Upgrade Problem 1 1
Defective Device 1 1
Sparking 1 1
Incorrect Or Inadequate Test Results 1 1
Loss of Power 1 1
Mechanical Problem 1 1
Melted 1 1
Migration or Expulsion of Device 1 1
No Audible Alarm 1 1
Unintended Arm Motion 1 1
False Negative Result 1 1
Fire 1 1
Fracture 1 1
Difficult to Open or Close 1 1
Appropriate Term/Code Not Available 1 1
Therapeutic or Diagnostic Output Failure 1 1
Unexpected Shutdown 1 1
Unintended Application Program Shut Down 1 1
Program or Algorithm Execution Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 456 456
No Clinical Signs, Symptoms or Conditions 82 82
No Consequences Or Impact To Patient 69 69
No Patient Involvement 36 36
No Information 20 20
No Code Available 7 7
Misdiagnosis 6 6
Insufficient Information 5 5
Failure of Implant 4 4
Missing Value Reason 4 4
Death 4 4
Inadequate Osseointegration 3 3
Patient Problem/Medical Problem 2 2
Pain 2 2
Stenosis 2 2
Radiation Overdose 2 2
Aortic Valve Stenosis 2 2
Arthritis 1 1
Crushing Injury 1 1
Inflammation 1 1
Lupus 1 1
Radiation Underdose 1 1
Ambulation Difficulties 1 1
Abscess 1 1
Complaint, Ill-Defined 1 1
Injury 1 1
Disability 1 1
Obstruction/Occlusion 1 1
Vascular System (Circulation), Impaired 1 1
Pneumothorax 1 1
Respiratory Distress 1 1
Seizures 1 1
Brain Injury 1 1
Radiation Exposure, Unintended 1 1
Not Applicable 1 1
Bone Fracture(s) 1 1
Liver Damage/Dysfunction 1 1

Recalls
Manufacturer Recall Class Date Posted
1 AGFA Healthcare Corp. II Jun-29-2017
2 AS Software, Inc. II Oct-16-2018
3 Agfa Healthcare NV II Oct-11-2018
4 Brainreader ApS II Jan-29-2021
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 Carestream Health Inc II May-02-2016
9 DICOM GRID INC II Jan-18-2017
10 EOS Imaging II Sep-18-2018
11 Fujifilm Medical Systems U.S.A., Inc. II Jun-02-2021
12 Fujifilm Medical Systems U.S.A., Inc. II Apr-02-2021
13 Fujifilm Medical Systems U.S.A., Inc. II Jan-22-2021
14 Fujifilm Medical Systems U.S.A., Inc. II Jan-17-2021
15 Fujifilm Medical Systems U.S.A., Inc. II Oct-22-2020
16 Fujifilm Medical Systems U.S.A., Inc. II Jun-30-2020
17 Fujifilm Medical Systems U.S.A., Inc. II Oct-12-2016
18 Fujifilm Medical Systems U.S.A., Inc. II Jun-21-2016
19 GE Healthcare II Jun-06-2018
20 GE Healthcare II Apr-03-2018
21 GE Healthcare It II Aug-17-2016
22 GE Healthcare, LLC II Sep-22-2021
23 GE Healthcare, LLC II May-05-2021
24 GE Healthcare, LLC II Jan-17-2020
25 GE Healthcare, LLC II Jul-01-2019
26 GE Healthcare, LLC II Jun-26-2019
27 GE Healthcare, LLC II Jun-13-2019
28 GE Healthcare, LLC II Feb-01-2019
29 GE Healthcare, LLC II Dec-19-2018
30 GE Healthcare, LLC II Nov-02-2018
31 GE Healthcare, LLC II Oct-18-2018
32 GE Healthcare, LLC II Dec-23-2016
33 Ge Healthcare It II Jul-28-2016
34 Ge Medical Systems Information T II Apr-11-2017
35 Immersivetouch Inc III May-18-2020
36 Invivo Corporation II Apr-02-2018
37 Koios Medical, Inc. II Jan-17-2020
38 Konica Minolta Medical Imaging USA, Inc. II Jun-22-2018
39 Mckesson Medical Imaging II Mar-02-2017
40 Mckesson Medical Imaging Group II Sep-22-2016
41 Mckesson Medical Immaging II Mar-17-2016
42 Medtronic Navigation, Inc. II Sep-26-2018
43 Merge Healthcare, Inc. II Sep-09-2020
44 Merge Healthcare, Inc. II Jun-19-2020
45 Merge Healthcare, Inc. II Jul-23-2019
46 Merge Healthcare, Inc. II Oct-11-2018
47 Merge Healthcare, Inc. II Aug-18-2017
48 Merge Healthcare, Inc. II Jun-22-2017
49 Merge Healthcare, Inc. II Jun-16-2017
50 Merge Healthcare, Inc. II Jun-15-2017
51 Merge Healthcare, Inc. II Jun-15-2017
52 Merge Healthcare, Inc. II May-22-2017
53 Merge Healthcare, Inc. II Mar-21-2017
54 Merge Healthcare, Inc. II Mar-20-2017
55 Merge Healthcare, Inc. II Mar-19-2017
56 Merge Healthcare, Inc. II Mar-09-2017
57 Merge Healthcare, Inc. II Mar-09-2017
58 Merge Healthcare, Inc. II Mar-08-2017
59 Merge Healthcare, Inc. II Mar-03-2017
60 Merge Healthcare, Inc. II Mar-02-2017
61 Merge Healthcare, Inc. II Feb-09-2017
62 Merge Healthcare, Inc. II Feb-09-2017
63 Merge Healthcare, Inc. II Jan-19-2017
64 Merge Healthcare, Inc. II Dec-30-2016
65 Merge Healthcare, Inc. II Dec-21-2016
66 Merge Healthcare, Inc. II Dec-09-2016
67 Merge Healthcare, Inc. II Dec-09-2016
68 Merge Healthcare, Inc. II Dec-08-2016
69 Merge Healthcare, Inc. II Dec-05-2016
70 Merge Healthcare, Inc. II Nov-18-2016
71 Merge Healthcare, Inc. II Nov-17-2016
72 Merge Healthcare, Inc. II Nov-17-2016
73 Merge Healthcare, Inc. II Oct-20-2016
74 Merge Healthcare, Inc. II Oct-19-2016
75 Merge Healthcare, Inc. II Oct-18-2016
76 Merge Healthcare, Inc. II Sep-22-2016
77 Merge Healthcare, Inc. II Sep-21-2016
78 Merge Healthcare, Inc. II Sep-14-2016
79 Merge Healthcare, Inc. II Sep-02-2016
80 Merge Healthcare, Inc. II Sep-01-2016
81 Merge Healthcare, Inc. II Aug-29-2016
82 Merge Healthcare, Inc. II Aug-23-2016
83 Merge Healthcare, Inc. II Aug-16-2016
84 Merge Healthcare, Inc. II Aug-12-2016
85 Merge Healthcare, Inc. II Aug-10-2016
86 Merge Healthcare, Inc. II Aug-08-2016
87 Merge Healthcare, Inc. II Jul-29-2016
88 Merge Healthcare, Inc. II Jul-29-2016
89 Merge Healthcare, Inc. II Jul-11-2016
90 Merge Healthcare, Inc. II Jul-08-2016
91 Merge Healthcare, Inc. II Feb-10-2016
92 NordicNeuroLab AS II Jun-04-2018
93 NordicNeuroLab AS II Jun-01-2018
94 NordicNeuroLab AS II Jun-01-2018
95 NordicNeuroLab AS II May-31-2018
96 NordicNeuroLab AS II May-31-2018
97 Novarad Corporation II Sep-12-2020
98 Novarad Corporation II Aug-25-2016
99 Novarad Corporation II Jul-11-2016
100 Novarad Corporation II May-06-2016
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