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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
Device system, image processing, radiological
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 ONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
3D SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
3DIEMME LTD.
  SUBSTANTIALLY EQUIVALENT 1
3SHAPE MEDICAL A/S
  SUBSTANTIALLY EQUIVALENT 1
ACROVIZ INC.
  SUBSTANTIALLY EQUIVALENT 1
ADAS3D MEDICAL S.L
  SUBSTANTIALLY EQUIVALENT 2
ADM DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ADVANTIS MEDICAL IMAGING SINGLE MEMBER P.C.
  SUBSTANTIALLY EQUIVALENT 1
AGFA HEALTHCARE N.V.
  SUBSTANTIALLY EQUIVALENT 1
AI MEDIC INC.
  SUBSTANTIALLY EQUIVALENT 1
AI METRICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
AI4MEDIMAGING MEDICAL SOLUTIONS S.A.
  SUBSTANTIALLY EQUIVALENT 1
AIBOLIT TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
AIQ SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
AIRS MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 2
ALPHATEC SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
ALTARAVISION INC.
  SUBSTANTIALLY EQUIVALENT 1
AMCAD BIOMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
ANATOMAGE INC.
  SUBSTANTIALLY EQUIVALENT 1
ANATOMAGE, INC
  SUBSTANTIALLY EQUIVALENT 1
ANGIOCLOUD, LLC
  SUBSTANTIALLY EQUIVALENT 1
APOLLO MEDICAL IMAGING TECHNOLOGY PTY. LTD.
  SUBSTANTIALLY EQUIVALENT 1
APTERYX, INC.
  SUBSTANTIALLY EQUIVALENT 1
ARTERYS INC.
  SUBSTANTIALLY EQUIVALENT 4
ARTHREX INC.
  SUBSTANTIALLY EQUIVALENT 1
ASCEND HIT
  SUBSTANTIALLY EQUIVALENT 1
ASSEMBLECIRCLE CORP.
  SUBSTANTIALLY EQUIVALENT 1
AXIAL MEDICAL PRINTING LIMITED
  SUBSTANTIALLY EQUIVALENT 1
BAY LABS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BB IMAGING
  SUBSTANTIALLY EQUIVALENT 1
BIOMET INC.
  SUBSTANTIALLY EQUIVALENT 1
BLUE BELT TECHNOLOGIES, 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
CANON MEDICAL SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 5
CARDIOWISE, INC.
  SUBSTANTIALLY EQUIVALENT 1
CARESTREAM HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 1
CARISTO DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1
CARL ZEISS MEDITEC AG
  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 2
CIRCLE CARDIOVASCULAR IMAGING INC.
  SUBSTANTIALLY EQUIVALENT 1
CLARIPI INC.
  SUBSTANTIALLY EQUIVALENT 3
CLARITAS HEALTHTECH PTE LTD
  SUBSTANTIALLY EQUIVALENT 2
CLEERLY INC
  SUBSTANTIALLY EQUIVALENT 1
CLEERLY, INC.
  SUBSTANTIALLY EQUIVALENT 1
CLIENT OUTLOOK INC.
  SUBSTANTIALLY EQUIVALENT 1
COMBINOSTICS OY
  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
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
DENSITAS, INC.
  SUBSTANTIALLY EQUIVALENT 2
DENTSPLY SIRONA
  SUBSTANTIALLY EQUIVALENT 2
DICOM GRID, INC, DBA AMBRA HEALTH
  SUBSTANTIALLY EQUIVALENT 1
DIGITALCORE CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
DISIOR LTD
  SUBSTANTIALLY EQUIVALENT 1
DOSISOFT
  SUBSTANTIALLY EQUIVALENT 1
DRGEM CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
DURR DENTAL SE
  SUBSTANTIALLY EQUIVALENT 3
DÜRR DENTAL SE
  SUBSTANTIALLY EQUIVALENT 1
DYAD MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
EBIT SRL
  SUBSTANTIALLY EQUIVALENT 1
EBM TECHNOLOGIES INC.
  SUBSTANTIALLY EQUIVALENT 1
EBM TECHNOLOGIES INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
ECHOPIXEL INC.
  SUBSTANTIALLY EQUIVALENT 2
ECHOPIXEL, INC.
  SUBSTANTIALLY EQUIVALENT 1
EIGEN
  SUBSTANTIALLY EQUIVALENT 1
ELUCID BIOIMAGING INC.
  SUBSTANTIALLY EQUIVALENT 2
ELUCID BIOIMAGING, INC.
  SUBSTANTIALLY EQUIVALENT 1
EOS IMAGING
  SUBSTANTIALLY EQUIVALENT 1
EVER FORTUNE.AI CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
EVOLVE PACS INC.
  SUBSTANTIALLY EQUIVALENT 1
EWOO SOFT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 8
EWOOSOFT CO., LTD
  SUBSTANTIALLY EQUIVALENT 6
EWOOSOFT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
EXAMION GMBH
  SUBSTANTIALLY EQUIVALENT 1
EXINI DIAGNOSTICS AB
  SUBSTANTIALLY EQUIVALENT 3
EXOCAD GMBH
  SUBSTANTIALLY EQUIVALENT 2
FH INDUSTRIE
  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 3
GALGO MEDICAL S.L
  SUBSTANTIALLY EQUIVALENT 1
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 4
GE MEDICAL SYSTEMS SCS
  SUBSTANTIALLY EQUIVALENT 4
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 2
GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIAGNOSTICS,
  SUBSTANTIALLY EQUIVALENT 1
HARMONUS INC.
  SUBSTANTIALLY EQUIVALENT 1
HDX WILL CORP.
  SUBSTANTIALLY EQUIVALENT 3
HERMES MEDICAL SOLUTIONS AB
  SUBSTANTIALLY EQUIVALENT 1
HEURON CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
HINACOM SOFTWARE AND TECHNOLOGY, LTD
  SUBSTANTIALLY EQUIVALENT 1
HOLOGIC, INC.
  SUBSTANTIALLY EQUIVALENT 2
HURA IMAGING, INC.
  SUBSTANTIALLY EQUIVALENT 1
HYPERFINE RESEARCH, INC
  SUBSTANTIALLY EQUIVALENT 1
IB LAB GMBH
  SUBSTANTIALLY EQUIVALENT 1
ICAD, INC
  SUBSTANTIALLY EQUIVALENT 1
ICOMETRIX
  SUBSTANTIALLY EQUIVALENT 1
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
IMMERSIVETOUCH, INC.
  SUBSTANTIALLY EQUIVALENT 1
IMPLANTER LLC
  SUBSTANTIALLY EQUIVALENT 1
INFINITT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
INFINITT HEALTHCARE CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 3
INHEART, SAS
  SUBSTANTIALLY EQUIVALENT 1
INTELERAD MEDICAL SYSTEMS INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
INTELLIJOINT SURGICAL INC.
  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
ISCHEMA VIEW INC.
  SUBSTANTIALLY EQUIVALENT 1
ISCHEMAVIEW, INC.
  SUBSTANTIALLY EQUIVALENT 2
JOINTVUE LLC
  SUBSTANTIALLY EQUIVALENT 3
JPI HEALTHCARE SOLUTIONS, INC
  SUBSTANTIALLY EQUIVALENT 1
KICO KNEE INNOVATION COMPANY PTY LIMITED
  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, 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
LIFETRACK MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
LIMBUS AI INC.
  SUBSTANTIALLY EQUIVALENT 1
MATERIALISE N.V.
  SUBSTANTIALLY EQUIVALENT 1
MATERIALISE NV
  SUBSTANTIALLY EQUIVALENT 4
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 3
MEDCOM GMBH
  SUBSTANTIALLY EQUIVALENT 2
MEDDIFF TECHNOLOGIES PVT. LTD.
  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
MEDICREA INTERNATIONAL, 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 2
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 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
NEUROPHET, INC.
  SUBSTANTIALLY EQUIVALENT 1
NINES, INC.
  SUBSTANTIALLY EQUIVALENT 1
NOBEL BIOCARE AB
  SUBSTANTIALLY EQUIVALENT 5
NORDICNEUROLAB AS
  SUBSTANTIALLY EQUIVALENT 2
NOVARAD CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
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 SAS
  SUBSTANTIALLY EQUIVALENT 1
OMNISCIENT NEUROTECHNOLOGY PTY LTD (O8T)
  SUBSTANTIALLY EQUIVALENT 1
ONEFIT MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ONEPACS, LLC
  SUBSTANTIALLY EQUIVALENT 1
OPTIMA HEALTH SOLUTIONS INTERNATIONAL CORP.
  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 2
ORYX DENTAL SOFTWARE INC
  SUBSTANTIALLY EQUIVALENT 1
OSKO, INC.
  SUBSTANTIALLY EQUIVALENT 1
OVERJET, INC.
  SUBSTANTIALLY EQUIVALENT 1
PALODEX GROUP OY
  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 DIAGNOSTICS LTD
  SUBSTANTIALLY EQUIVALENT 1
PERSPECTUM LTD.
  SUBSTANTIALLY EQUIVALENT 1
PHANTOMICS INC.
  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 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 2
PIXEE MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
PLANMECA OY
  SUBSTANTIALLY EQUIVALENT 2
PLUM MEDICAL SOLUTIONS GMBH
  SUBSTANTIALLY EQUIVALENT 1
PRECISIONOS TECHNOLOGY INC.
  SUBSTANTIALLY EQUIVALENT 1
PRODIGIDENT, INC.
  SUBSTANTIALLY EQUIVALENT 1
PROKNOW LLC
  SUBSTANTIALLY EQUIVALENT 1
QLARITY IMAGING
  SUBSTANTIALLY EQUIVALENT 1
QUANTIB B.V.
  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
RADISEN CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
RAYENCE CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
RAYENCE CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
REAL VIEW IMAGING LTD.
  SUBSTANTIALLY EQUIVALENT 1
RESOUNDANT INC
  SUBSTANTIALLY EQUIVALENT 1
RICOH USA, INC.
  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
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 3
SIEMENS MEDICAL SOLUTIONS USA INC.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS MEDICAL SOLUTIONS USA, INC.
  SUBSTANTIALLY EQUIVALENT 13
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
SIGMA SCIENTIFIC SERVICES LLC
  SUBSTANTIALLY EQUIVALENT 1
SMARTTARGET, LTD.
  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 2
SURGICAL INFORMATION SCIENCES, INC.
  SUBSTANTIALLY EQUIVALENT 4
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
TAIHAO MEDICAL 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 2
TROPHY
  SUBSTANTIALLY EQUIVALENT 1
UC-CARE LTD.
  SUBSTANTIALLY EQUIVALENT 2
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 3
VITAL IMAGES, INC
  SUBSTANTIALLY EQUIVALENT 1
VITAL IMAGES, INC.
  SUBSTANTIALLY EQUIVALENT 4
VIZ.AI, INC.
  SUBSTANTIALLY EQUIVALENT 1
VOLPARA HEALTH TECHNOLOGIES LIMITED
  SUBSTANTIALLY EQUIVALENT 2
VUZE MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
XORAN TECHNOLOGIES LLC
  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
2017 104 104
2018 72 72
2019 88 88
2020 82 82
2021 70 70
2022 18 18

Device Problems MDRs with this Device Problem Events in those MDRs
Computer Software Problem 140 140
Loss of Data 124 124
Use of Device Problem 72 72
Data Problem 40 40
Application Program Problem: Parameter Calculation Error 29 29
Patient Data Problem 23 23
Adverse Event Without Identified Device or Use Problem 21 21
Improper or Incorrect Procedure or Method 13 13
Application Program Problem 13 13
Device Issue 12 12
Data Back-Up Problem 7 7
Insufficient Information 6 6
No Apparent Adverse Event 5 5
Application Interface Becomes Non-Functional Or Program Exits Abnormally 5 5
Image Display Error/Artifact 5 5
Device Displays Incorrect Message 4 4
Output Problem 4 4
Device Operates Differently Than Expected 4 4
Device Operational Issue 4 4
Communication or Transmission Problem 3 3
Missing Test Results 3 3
Defective Component 3 3
Image Orientation Incorrect 3 3
Incorrect Measurement 3 3
Display or Visual Feedback Problem 3 3
Device Inoperable 2 2
No Display/Image 2 2
Incorrect, Inadequate or Imprecise Resultor Readings 2 2
Problem with Software Installation 2 2
Improper Device Output 2 2
Inadequate User Interface 2 2
Compatibility Problem 1 1
Material Deformation 1 1
Measurement System Incompatibility 1 1
Programming Issue 1 1
Reset Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Electrical Power Problem 1 1
Electrical Shorting 1 1
Facilities Issue 1 1
Human Factors Issue 1 1
Human-Device Interface Problem 1 1
Unexpected Shutdown 1 1
No Visual Prompts/Feedback 1 1
Application Program Freezes, Becomes Nonfunctional 1 1
Unintended Application Program Shut Down 1 1
Program or Algorithm Execution Failure 1 1
Computer Operating System Problem 1 1
Connection Problem 1 1
Material Rupture 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
Application Program Version or Upgrade Problem 1 1
Battery Problem 1 1
Defective Device 1 1
Electrical /Electronic Property Problem 1 1
False Negative Result 1 1
Fire 1 1
No Audible Alarm 1 1
Unintended Arm Motion 1 1
Failure to Back-Up 1 1
Failure to Convert to Back-Up 1 1
Break 1 1
Mechanical Problem 1 1
Poor Quality Image 1 1
Nonstandard Device 1 1
Image Resolution Poor 1 1
Kinked 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 232 232
No Clinical Signs, Symptoms or Conditions 112 112
No Consequences Or Impact To Patient 50 50
No Patient Involvement 17 17
Insufficient Information 7 7
Misdiagnosis 5 5
No Information 4 4
Pneumothorax 2 2
Unintended Radiation Exposure 2 2
Stenosis 2 2
Radiation Overdose 2 2
Aortic Valve Stenosis 2 2
Death 2 2
Bone Fracture(s) 1 1
Hemorrhage/Bleeding 1 1
Inflammation 1 1
Lupus 1 1
Pain 1 1
Arthritis 1 1
Crushing Injury 1 1
Abscess 1 1
Complaint, Ill-Defined 1 1
Disability 1 1
Ambulation Difficulties 1 1
Vascular System (Circulation), Impaired 1 1
Radiation Underdose 1 1
Brain Injury 1 1
No Code Available 1 1
Missing Value Reason 1 1
Cancer 1 1
Thrombosis/Thrombus 1 1
Patient Problem/Medical Problem 1 1
Radiation Exposure, Unintended 1 1
Not Applicable 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 DICOM GRID INC II Jan-18-2017
9 EOS Imaging II Sep-18-2018
10 Fujifilm Medical Systems U.S.A., Inc. II Jun-02-2021
11 Fujifilm Medical Systems U.S.A., Inc. II Apr-02-2021
12 Fujifilm Medical Systems U.S.A., Inc. II Jan-22-2021
13 Fujifilm Medical Systems U.S.A., Inc. II Jan-17-2021
14 Fujifilm Medical Systems U.S.A., Inc. II Oct-22-2020
15 Fujifilm Medical Systems U.S.A., Inc. II Jun-30-2020
16 GE Healthcare II Jun-06-2018
17 GE Healthcare II Apr-03-2018
18 GE Healthcare, LLC II Aug-24-2022
19 GE Healthcare, LLC II Jul-25-2022
20 GE Healthcare, LLC II Jul-05-2022
21 GE Healthcare, LLC II Jun-03-2022
22 GE Healthcare, LLC II Dec-02-2021
23 GE Healthcare, LLC II Oct-02-2021
24 GE Healthcare, LLC II Sep-22-2021
25 GE Healthcare, LLC II May-05-2021
26 GE Healthcare, LLC II Jan-17-2020
27 GE Healthcare, LLC II Jul-01-2019
28 GE Healthcare, LLC II Jun-26-2019
29 GE Healthcare, LLC II Jun-13-2019
30 GE Healthcare, LLC II Feb-01-2019
31 GE Healthcare, LLC II Dec-19-2018
32 GE Healthcare, LLC II Nov-02-2018
33 GE Healthcare, LLC II Oct-18-2018
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 Healthcare Americas, Inc. II Jan-14-2022
39 Konica Minolta Medical Imaging USA, Inc. II Jun-22-2018
40 Mckesson Medical Imaging II Mar-02-2017
41 Medtronic Navigation, Inc. II Sep-26-2018
42 Merge Healthcare, Inc. II Sep-09-2020
43 Merge Healthcare, Inc. II Jun-19-2020
44 Merge Healthcare, Inc. II Jul-23-2019
45 Merge Healthcare, Inc. II Oct-11-2018
46 Merge Healthcare, Inc. II Aug-18-2017
47 Merge Healthcare, Inc. II Jun-22-2017
48 Merge Healthcare, Inc. II Jun-16-2017
49 Merge Healthcare, Inc. II Jun-15-2017
50 Merge Healthcare, Inc. II Jun-15-2017
51 Merge Healthcare, Inc. II May-22-2017
52 Merge Healthcare, Inc. II Mar-21-2017
53 Merge Healthcare, Inc. II Mar-20-2017
54 Merge Healthcare, Inc. II Mar-19-2017
55 Merge Healthcare, Inc. II Mar-09-2017
56 Merge Healthcare, Inc. II Mar-09-2017
57 Merge Healthcare, Inc. II Mar-08-2017
58 Merge Healthcare, Inc. II Mar-03-2017
59 Merge Healthcare, Inc. II Mar-02-2017
60 Merge Healthcare, Inc. II Feb-09-2017
61 Merge Healthcare, Inc. II Feb-09-2017
62 Merge Healthcare, Inc. II Jan-19-2017
63 NordicNeuroLab AS II Jul-25-2022
64 NordicNeuroLab AS II Jun-04-2018
65 NordicNeuroLab AS II Jun-01-2018
66 NordicNeuroLab AS II Jun-01-2018
67 NordicNeuroLab AS II May-31-2018
68 NordicNeuroLab AS II May-31-2018
69 Novarad Corporation II Sep-12-2020
70 Ortho Kinematics, Inc II Aug-22-2018
71 Ortho Kinematics, Inc II Aug-22-2018
72 Ortho Kinematics, Inc II Aug-22-2018
73 Ortho Kinematics, Inc II Aug-21-2018
74 Philips Healthcare Informatics, Inc. II Jun-10-2020
75 Philips North America, LLC II Jan-13-2021
76 Philips North America Llc II Apr-06-2022
77 SICAT GMBH & CO. KG II Sep-10-2020
78 Siemens Medical Solutions USA, Inc II May-09-2018
79 Siemens Medical Solutions USA, Inc II May-07-2018
80 Siemens Medical Solutions USA, Inc II Mar-28-2018
81 Siemens Medical Solutions USA, Inc II Mar-20-2018
82 Siemens Medical Solutions USA, Inc II Mar-01-2018
83 Siemens Medical Solutions USA, Inc II Feb-05-2018
84 Siemens Medical Solutions USA, Inc II Jan-31-2018
85 Siemens Medical Solutions USA, Inc II Nov-21-2017
86 Siemens Medical Solutions USA, Inc II Mar-27-2017
87 Siemens Medical Solutions USA, Inc II Mar-10-2017
88 Siemens Medical Solutions USA, Inc II Jan-31-2017
89 Siemens Medical Solutions USA, Inc. II Jan-23-2018
90 Simpleware Product Group, SYNOPSYS NORTHERN EUROPE II Aug-12-2021
91 Synaptive Medical Inc II Apr-22-2020
92 Tomtec Imaging Systems Gmbh II Jul-04-2020
93 Zimmer Biomet, Inc. II Mar-13-2017
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