TPLC - Total Product Life Cycle

• 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	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