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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 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 1
BAY LABS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BB IMAGING
  SUBSTANTIALLY EQUIVALENT 1
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
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 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 1
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
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 6
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
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 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
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
IRM INC
  SUBSTANTIALLY EQUIVALENT 1
ISCHEMA VIEW INC.
  SUBSTANTIALLY EQUIVALENT 1
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
LIMBUS AI INC.
  SUBSTANTIALLY EQUIVALENT 2
MATERIALISE N.V.
  SUBSTANTIALLY EQUIVALENT 1
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
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
NINES, INC.
  SUBSTANTIALLY EQUIVALENT 1
NOBEL BIOCARE AB
  SUBSTANTIALLY EQUIVALENT 4
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
OPTIMA HEALTH SOLUTIONS INTERNATIONAL CORP.
  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 1
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, 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
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
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
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 3
SHANGHAI UNITED IMAGING HEALTHCARE CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 3
SICAT GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS HEALTHCARE GMBH
  SUBSTANTIALLY EQUIVALENT 8
SIEMENS MEDICAL SOLUTION USA, INC.
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS MEDICAL SOLUTIONS USA INC.
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS MEDICAL SOLUTIONS USA, INC.
  SUBSTANTIALLY EQUIVALENT 10
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
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 2
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 20 20

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