|
Device |
system, image processing, radiological |
Product Code | LLZ |
Regulation Number |
892.2050
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
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
|
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
|
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
|
4
|
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
|
4
|
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
|
COMBINOSTICS OY |
|
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
|
2
|
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
|
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
|
4
|
EWOOSOFT CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
8
|
EWOOSOFT CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
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 HEALTHCARE GMBH |
|
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
|
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
|
JLK, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
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
|
LG ELECTRONICS.INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LIMBUS AI INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
LONGWOOD VALLEY MEDICAL LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MATERIALISE N.V. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
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
|
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
|
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
|
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
|
MICROSTRUCTURE IMAGING, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MIM SOFTWARE INC. |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
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
|
3
|
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
|
4
|
1. K200713 EchoNavigator
|
2. K201573 Brain Perfusion (BP) application
|
3. K221270 EchoNavigator R4.0
|
4. K242512 ROCC Console
|
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
|
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
|
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
|
4
|
SICAT GMBH & CO. KG |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
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
|
1
|
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
|
4
|
SURGICAL INFORMATION SCIENCES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
SURGICAL THEATER, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SYNOPSYS (NORTHERN EUROPE) LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SYNTHESIS HEALTH INTELLIGENCE INC |
|
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
|
TURING MEDICAL TECHNOLOGIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VENTRIPOINT DIAGNOSTICS, LTD. |
|
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
|
|
Recalls |
Manufacturer |
Recall Class |
Date Posted |
1 |
Agfa Healthcare NV |
II |
Oct-10-2024 |
2 |
Agfa Healthcare NV |
II |
Jan-20-2023 |
3 |
Brainreader ApS |
II |
Jan-29-2021 |
4 |
CHANGE HEALTHCARE CANADA COMPANY |
II |
Dec-14-2023 |
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 |
Exocad GmbH |
II |
Sep-25-2023 |
12 |
FUJIFILM Healthcare Americas Corporation |
II |
Mar-07-2024 |
13 |
FUJIFILM Healthcare Americas Corporation |
II |
Feb-21-2024 |
14 |
Fujifilm Medical Systems U.S.A., Inc. |
II |
Jun-02-2021 |
15 |
Fujifilm Medical Systems U.S.A., Inc. |
II |
Apr-02-2021 |
16 |
Fujifilm Medical Systems U.S.A., Inc. |
II |
Jan-22-2021 |
17 |
Fujifilm Medical Systems U.S.A., Inc. |
II |
Jan-17-2021 |
18 |
Fujifilm Medical Systems U.S.A., Inc. |
II |
Oct-22-2020 |
19 |
Fujifilm Medical Systems U.S.A., Inc. |
II |
Jun-30-2020 |
20 |
GE Healthcare |
II |
Nov-07-2024 |
21 |
GE Healthcare |
II |
Oct-09-2024 |
22 |
GE Healthcare |
II |
Sep-24-2024 |
23 |
GE Healthcare |
II |
Sep-17-2024 |
24 |
GE Healthcare |
II |
Oct-23-2023 |
25 |
GE Healthcare |
II |
Oct-20-2023 |
26 |
GE Healthcare |
II |
May-02-2023 |
27 |
GE Healthcare GmbH |
II |
Sep-13-2024 |
28 |
GE Healthcare, LLC |
II |
Aug-24-2022 |
29 |
GE Healthcare, LLC |
II |
Jul-25-2022 |
30 |
GE Healthcare, LLC |
II |
Jul-05-2022 |
31 |
GE Healthcare, LLC |
II |
Jun-03-2022 |
32 |
GE Healthcare, LLC |
II |
Dec-02-2021 |
33 |
GE Healthcare, LLC |
II |
Oct-02-2021 |
34 |
GE Healthcare, LLC |
II |
Sep-22-2021 |
35 |
GE Healthcare, LLC |
II |
May-05-2021 |
36 |
GE Healthcare, LLC |
II |
Jan-17-2020 |
37 |
GE Healthcare, LLC |
II |
Jul-01-2019 |
38 |
GE Healthcare, LLC |
II |
Jun-26-2019 |
39 |
GE Healthcare, LLC |
II |
Jun-13-2019 |
40 |
GE Healthcare, LLC |
II |
Feb-01-2019 |
41 |
GE Medical Systems, LLC |
II |
Dec-16-2022 |
42 |
Immersivetouch Inc |
III |
May-18-2020 |
43 |
Koios Medical, Inc. |
II |
Jan-17-2020 |
44 |
Konica Minolta Healthcare Americas, Inc. |
II |
Jan-14-2022 |
45 |
Merge Healthcare, Inc. |
II |
Sep-09-2020 |
46 |
Merge Healthcare, Inc. |
II |
Jun-19-2020 |
47 |
Merge Healthcare, Inc. |
II |
Jul-23-2019 |
48 |
NordicNeuroLab AS |
II |
Jul-25-2022 |
49 |
Novarad Corporation |
II |
Sep-12-2020 |
50 |
OLEA MEDICAL |
II |
Oct-18-2023 |
51 |
Philips Healthcare Informatics, Inc. |
II |
Jun-10-2020 |
52 |
Philips North America, LLC |
II |
Jan-13-2021 |
53 |
Philips North America Llc |
II |
Apr-06-2022 |
54 |
SICAT GMBH & CO. KG |
II |
Sep-10-2020 |
55 |
Simpleware Product Group, SYNOPSYS NORTHERN EUROPE |
II |
Aug-12-2021 |
56 |
Synaptive Medical Inc |
II |
Apr-22-2020 |
57 |
Tomtec Imaging Systems Gmbh |
II |
Jul-04-2020 |
58 |
Virtual Radiologic Corp. |
II |
Jul-21-2023 |
|
|
|
|