TPLC - Total Product Life Cycle

• Device: system, image processing, radiological
• Regulation Description: Picture archiving and communications system.
• 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 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