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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
Regulation Description Picture archiving and communications system.
Product CodeLLZ
Regulation Number 892.2050
Device Class 2


Premarket Reviews
ManufacturerDecision
3D INDUSTRIAL IMAGING CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
3SHAPE A/S
  SUBSTANTIALLY EQUIVALENT 1
4QIMAGING, LLC DBA QMETRICS
  SUBSTANTIALLY EQUIVALENT 1
AGFA HEALTHCARE N.V.
  SUBSTANTIALLY EQUIVALENT 2
ALTARAVISION INC.
  SUBSTANTIALLY EQUIVALENT 1
AMCAD BIOMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
ANATOMAGE INC.
  SUBSTANTIALLY EQUIVALENT 1
ANATOMAGE, INC
  SUBSTANTIALLY EQUIVALENT 1
APTERYX, INC.
  SUBSTANTIALLY EQUIVALENT 1
ARTERYS INC.
  SUBSTANTIALLY EQUIVALENT 5
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOBOT SURGICAL PTE LTD
  SUBSTANTIALLY EQUIVALENT 1
BRAINLAB AG
  SUBSTANTIALLY EQUIVALENT 4
CALGARY SCIENTIFIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
CANON MEDICAL SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
CARESTREAM DENTAL LLC
  SUBSTANTIALLY EQUIVALENT 1
CEEVRA, INC.
  SUBSTANTIALLY EQUIVALENT 2
CHANGE HEALTHCARE CANADA COMPANY
  SUBSTANTIALLY EQUIVALENT 2
CLEARVIEW DIAGNOSTICS INC.
  SUBSTANTIALLY EQUIVALENT 1
CLIENT OUTLOOK INC.
  SUBSTANTIALLY EQUIVALENT 2
COMPANIA MEXICANA DE RADIOLOGIA CGR, S.A. DE C.V.
  SUBSTANTIALLY EQUIVALENT 1
CORIN USA
  SUBSTANTIALLY EQUIVALENT 4
CORIN USA LIMITED
  SUBSTANTIALLY EQUIVALENT 1
CORTECHS LABS, INC
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN, LLC
  SUBSTANTIALLY EQUIVALENT 1
CURVEBEAM
  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
DICOM GRID INC.
  SUBSTANTIALLY EQUIVALENT 1
DOSISOFT
  SUBSTANTIALLY EQUIVALENT 1
DRGEM CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
DUERR DENTAL AG
  SUBSTANTIALLY EQUIVALENT 1
ECHOPIXEL INC.
  SUBSTANTIALLY EQUIVALENT 2
ECHOPIXEL, INC.
  SUBSTANTIALLY EQUIVALENT 1
EIGEN
  SUBSTANTIALLY EQUIVALENT 2
EOS IMAGING
  SUBSTANTIALLY EQUIVALENT 1
EV3 INC.
  SUBSTANTIALLY EQUIVALENT 1
EXINI DIAGNOSTICS AB
  SUBSTANTIALLY EQUIVALENT 1
EXOCAD GMBH
  SUBSTANTIALLY EQUIVALENT 1
FH ORTHOPEDICS
  SUBSTANTIALLY EQUIVALENT 1
FOCAL HEALTHCARE INC.
  SUBSTANTIALLY EQUIVALENT 1
FUJIFILM CORPORATION
  SUBSTANTIALLY EQUIVALENT 8
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 8
GE MEDICAL SYSTEMS, SCS
  SUBSTANTIALLY EQUIVALENT 1
GENERAL ELECTRIC CO.
  SUBSTANTIALLY EQUIVALENT 8
HDX WILL CORP.
  SUBSTANTIALLY EQUIVALENT 2
HEART IMAGING TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
HECTEC GMBH
  SUBSTANTIALLY EQUIVALENT 2
HEPATIQ LLC
  SUBSTANTIALLY EQUIVALENT 1
HOLOGIC, INC.
  SUBSTANTIALLY EQUIVALENT 2
ICOMETRIX
  SUBSTANTIALLY EQUIVALENT 2
ICOMETRIX NV
  SUBSTANTIALLY EQUIVALENT 3
IMAGING BIOMETRICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
INFINITT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
INTELERAD MEDICAL SYSTEMS INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
INTUITIVE SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
INVIVO
  SUBSTANTIALLY EQUIVALENT 3
ISCHEMAVIEW, INC.
  SUBSTANTIALLY EQUIVALENT 2
KONICA MINOLTA, INC.
  SUBSTANTIALLY EQUIVALENT 3
LG ELECTRONICS
  SUBSTANTIALLY EQUIVALENT 1
LIFETRACK MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MATERIALISE N.V.
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 1
MEDCOM GMBH
  SUBSTANTIALLY EQUIVALENT 2
MEDIA LAB S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
MEDICREA INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 2
MEDSYNAPTIC PRIVATE, LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDVISO AB
  SUBSTANTIALLY EQUIVALENT 1
MEGAGEN IMPLANT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MERGE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 4
MERIDIAN TECHNIQUE LTD
  SUBSTANTIALLY EQUIVALENT 1
MICROSOFT CORP.
  SUBSTANTIALLY EQUIVALENT 1
MIM SOFTWARE INC.
  SUBSTANTIALLY EQUIVALENT 5
MIRADA MEDICAL LTD
  SUBSTANTIALLY EQUIVALENT 1
NOBEL BIOCARE
  SUBSTANTIALLY EQUIVALENT 5
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
OLEA MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ONEFIT MEDICAL
  SUBSTANTIALLY EQUIVALENT 4
ONEPACS, LLC
  SUBSTANTIALLY EQUIVALENT 1
ORTHO KINEMATICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
ORTHOFIX
  SUBSTANTIALLY EQUIVALENT 1
ORTHOFIX SRL
  SUBSTANTIALLY EQUIVALENT 1
OSKO, INC.
  SUBSTANTIALLY EQUIVALENT 1
PALODEX GROUP OY
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 5
PHILIPS MEDICAL SYSTEMS INTERNATIONAL BV
  SUBSTANTIALLY EQUIVALENT 14
PHILIPS MEDICAL SYSTEMS NEDERLANDS B.V.
  SUBSTANTIALLY EQUIVALENT 1
PICOFEMTO LLC
  SUBSTANTIALLY EQUIVALENT 1
PIE MEDICAL IMAGING B.V.
  SUBSTANTIALLY EQUIVALENT 3
PLANMECA OY
  SUBSTANTIALLY EQUIVALENT 2
QI IMAGING, LLC
  SUBSTANTIALLY EQUIVALENT 2
QUANTIB BV
  SUBSTANTIALLY EQUIVALENT 6
QUANTITATIVE INSIGHTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
RAYENCE CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
SAMSUNG MEDISON CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SICAT GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS
  SUBSTANTIALLY EQUIVALENT 17
SIEMENS CAPITAL
  SUBSTANTIALLY EQUIVALENT 14
SIEMENS HEALTHCARE GMBH
  SUBSTANTIALLY EQUIVALENT 7
SIEMENS MEDICAL SOLUTION USA, INC.
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS MEDICAL SOLUTIONS USA, INC
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS MEDICAL SOLUTIONS USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
STATLIFE
  SUBSTANTIALLY EQUIVALENT 2
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1
SURGICAL THEATER, LLC
  SUBSTANTIALLY EQUIVALENT 2
SYNAPTIVE MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 2
TERARECON, INC.
  SUBSTANTIALLY EQUIVALENT 1
THERENVA SAS
  SUBSTANTIALLY EQUIVALENT 1
TOSHIBA
  SUBSTANTIALLY EQUIVALENT 2
TOSHIBA MEDICAL SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
TROPHY
  SUBSTANTIALLY EQUIVALENT 1
UC-CARE LTD.
  SUBSTANTIALLY EQUIVALENT 2
VARIAN
  SUBSTANTIALLY EQUIVALENT 1
VARIAN MEDICAL SYSTEMS, INC
  SUBSTANTIALLY EQUIVALENT 1
VIDAR SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
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 6
VOLPARA HEALTH TECHNOLOGIES LIMITED
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 290 290
2017 104 104
2018 72 72
2019 88 88
2020 81 81

Device Problems MDRs with this Device Problem Events in those MDRs
Computer Software Problem 168 168
Loss of Data 135 135
Data Problem 108 108
Use of Device Problem 72 72
Patient Data Problem 52 52
Device Operates Differently Than Expected 47 47
Device Issue 37 37
Adverse Event Without Identified Device or Use Problem 26 26
Device Operational Issue 18 18
Application Program Problem 14 14
Improper or Incorrect Procedure or Method 13 13
Application Program Problem: Parameter Calculation Error 12 12
Overheating of Device 10 10
Smoking 9 9
Incorrect Measurement 7 7
Computer Operating System Problem 7 7
Application Interface Becomes Non-Functional Or Program Exits Abnormally 7 7
Data Back-Up Problem 7 7
Image Display Error/Artifact 6 6
Device Displays Incorrect Message 6 6
Device Inoperable 5 5
Image Orientation Incorrect 5 5
Programming Issue 5 5
Insufficient Information 5 5
Display or Visual Feedback Problem 5 5
Output Problem 5 5
Patient-Device Incompatibility 4 4
Incorrect, Inadequate or Imprecise Resultor Readings 4 4
No Apparent Adverse Event 4 4
User Interface 4 4
Decoder 4 4
Poor Quality Image 4 4
Positioning Problem 4 4
Fitting Problem 3 3
Improper Device Output 3 3
Missing Test Results 3 3
Nonstandard Device 3 3
No Display/Image 3 3
Communication or Transmission Problem 3 3
Structural Problem 2 2
Problem with Software Installation 2 2
Human Factors Issue 2 2
Break 2 2
Incorrect Software Programming Calculations 2 2
Device Stops Intermittently 2 2
Failure to Read Input Signal 2 2
Failure to Back-Up 2 2
Display Difficult to Read 2 2
Erratic or Intermittent Display 1 1
Electrical /Electronic Property Problem 1 1
Failure to Convert to Back-Up 1 1
Image Resolution Poor 1 1
Kinked 1 1
Unable to Obtain Readings 1 1
Material Rupture 1 1
Self-Activation or Keying 1 1
Inadequacy of Device Shape and/or Size 1 1
Unstable 1 1
Compatibility Problem 1 1
Material Deformation 1 1
Malposition of Device 1 1
Battery Problem 1 1
Electrical Power Problem 1 1
Electrical Shorting 1 1
Facilities Issue 1 1
No Visual Prompts/Feedback 1 1
Melted 1 1
Migration or Expulsion of Device 1 1
Loss of Power 1 1
Failure to Power Up 1 1
No Audible Alarm 1 1
Unintended Arm Motion 1 1
False Negative Result 1 1
Fire 1 1
Fracture 1 1
Human-Device Interface Problem 1 1
Installation-Related Problem 1 1
Measurement System Incompatibility 1 1
Difficult to Open or Close 1 1
Defective Device 1 1
Sparking 1 1
Incorrect Or Inadequate Test Results 1 1
Application Program Version or Upgrade Problem 1 1
Program or Algorithm Execution Failure 1 1
Appropriate Term/Code Not Available 1 1
Therapeutic or Diagnostic Output Failure 1 1
Viewer 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 456 456
No Consequences Or Impact To Patient 68 68
No Patient Involvement 36 36
No Clinical Signs, Symptoms or Conditions 30 30
No Information 20 20
No Code Available 7 7
Misdiagnosis 6 6
Failure of Implant 4 4
Missing Value Reason 4 4
Death 4 4
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
Insufficient Information 1 1
Complaint, Ill-Defined 1 1
Injury 1 1
Disability 1 1
Obstruction/Occlusion 1 1
Vascular System (Circulation), Impaired 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
Inadequate Osseointegration 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 CHANGE HEALTHCARE CANADA COMPANY II Oct-08-2020
5 Carestream Health Inc II May-02-2016
6 DICOM GRID INC II Jan-18-2017
7 EOS Imaging II Sep-18-2018
8 Fujifilm Medical Systems U.S.A., Inc. II Jan-17-2021
9 Fujifilm Medical Systems U.S.A., Inc. II Oct-22-2020
10 Fujifilm Medical Systems U.S.A., Inc. II Jun-30-2020
11 Fujifilm Medical Systems U.S.A., Inc. II Oct-12-2016
12 Fujifilm Medical Systems U.S.A., Inc. II Jun-21-2016
13 GE Healthcare II Jun-06-2018
14 GE Healthcare II Apr-03-2018
15 GE Healthcare It II Aug-17-2016
16 GE Healthcare, LLC II Jan-17-2020
17 GE Healthcare, LLC II Jul-01-2019
18 GE Healthcare, LLC II Jun-26-2019
19 GE Healthcare, LLC II Jun-13-2019
20 GE Healthcare, LLC II Feb-01-2019
21 GE Healthcare, LLC II Dec-19-2018
22 GE Healthcare, LLC II Nov-02-2018
23 GE Healthcare, LLC II Oct-18-2018
24 GE Healthcare, LLC II Dec-23-2016
25 Ge Healthcare It II Jul-28-2016
26 Ge Medical Systems Information T II Apr-11-2017
27 Immersivetouch Inc III May-18-2020
28 Invivo Corporation II Apr-02-2018
29 Koios Medical, Inc. II Jan-17-2020
30 Konica Minolta Medical Imaging USA, Inc. II Jun-22-2018
31 Mckesson Medical Imaging II Mar-02-2017
32 Mckesson Medical Imaging Group II Sep-22-2016
33 Mckesson Medical Immaging II Mar-17-2016
34 Medtronic Navigation, Inc. II Sep-26-2018
35 Merge Healthcare, Inc. II Sep-09-2020
36 Merge Healthcare, Inc. II Jun-19-2020
37 Merge Healthcare, Inc. II Jul-23-2019
38 Merge Healthcare, Inc. II Oct-11-2018
39 Merge Healthcare, Inc. II Aug-18-2017
40 Merge Healthcare, Inc. II Jun-22-2017
41 Merge Healthcare, Inc. II Jun-16-2017
42 Merge Healthcare, Inc. II Jun-15-2017
43 Merge Healthcare, Inc. II Jun-15-2017
44 Merge Healthcare, Inc. II May-22-2017
45 Merge Healthcare, Inc. II Mar-21-2017
46 Merge Healthcare, Inc. II Mar-20-2017
47 Merge Healthcare, Inc. II Mar-19-2017
48 Merge Healthcare, Inc. II Mar-09-2017
49 Merge Healthcare, Inc. II Mar-09-2017
50 Merge Healthcare, Inc. II Mar-08-2017
51 Merge Healthcare, Inc. II Mar-03-2017
52 Merge Healthcare, Inc. II Mar-02-2017
53 Merge Healthcare, Inc. II Feb-09-2017
54 Merge Healthcare, Inc. II Feb-09-2017
55 Merge Healthcare, Inc. II Jan-19-2017
56 Merge Healthcare, Inc. II Dec-30-2016
57 Merge Healthcare, Inc. II Dec-21-2016
58 Merge Healthcare, Inc. II Dec-09-2016
59 Merge Healthcare, Inc. II Dec-09-2016
60 Merge Healthcare, Inc. II Dec-08-2016
61 Merge Healthcare, Inc. II Dec-05-2016
62 Merge Healthcare, Inc. II Nov-18-2016
63 Merge Healthcare, Inc. II Nov-17-2016
64 Merge Healthcare, Inc. II Nov-17-2016
65 Merge Healthcare, Inc. II Oct-20-2016
66 Merge Healthcare, Inc. II Oct-19-2016
67 Merge Healthcare, Inc. II Oct-18-2016
68 Merge Healthcare, Inc. II Sep-22-2016
69 Merge Healthcare, Inc. II Sep-21-2016
70 Merge Healthcare, Inc. II Sep-14-2016
71 Merge Healthcare, Inc. II Sep-02-2016
72 Merge Healthcare, Inc. II Sep-01-2016
73 Merge Healthcare, Inc. II Aug-29-2016
74 Merge Healthcare, Inc. II Aug-23-2016
75 Merge Healthcare, Inc. II Aug-16-2016
76 Merge Healthcare, Inc. II Aug-12-2016
77 Merge Healthcare, Inc. II Aug-10-2016
78 Merge Healthcare, Inc. II Aug-08-2016
79 Merge Healthcare, Inc. II Jul-29-2016
80 Merge Healthcare, Inc. II Jul-29-2016
81 Merge Healthcare, Inc. II Jul-11-2016
82 Merge Healthcare, Inc. II Jul-08-2016
83 Merge Healthcare, Inc. II Feb-10-2016
84 NordicNeuroLab AS II Jun-04-2018
85 NordicNeuroLab AS II Jun-01-2018
86 NordicNeuroLab AS II Jun-01-2018
87 NordicNeuroLab AS II May-31-2018
88 NordicNeuroLab AS II May-31-2018
89 Novarad Corporation II Sep-12-2020
90 Novarad Corporation II Aug-25-2016
91 Novarad Corporation II Jul-11-2016
92 Novarad Corporation II May-06-2016
93 Ortho Kinematics, Inc II Aug-22-2018
94 Ortho Kinematics, Inc II Aug-22-2018
95 Ortho Kinematics, Inc II Aug-22-2018
96 Ortho Kinematics, Inc II Aug-21-2018
97 Philips Electronics North America Corporation II Aug-29-2016
98 Philips Healthcare Informatics, Inc. II Jun-10-2020
99 Philips North America, LLC II Jan-13-2021
100 SICAT GMBH & CO. KG II Sep-10-2020
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