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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
3DISC AMERICAS
  SUBSTANTIALLY EQUIVALENT 1
3SHAPE A/S
  SUBSTANTIALLY EQUIVALENT 1
4QIMAGING, LLC DBA QMETRICS
  SUBSTANTIALLY EQUIVALENT 1
AGFA HEALTHCARE N.V.
  SUBSTANTIALLY EQUIVALENT 4
ALTARAVISION INC.
  SUBSTANTIALLY EQUIVALENT 1
AMCAD BIOMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
ANATOMAGE INC.
  SUBSTANTIALLY EQUIVALENT 2
ANATOMAGE, INC
  SUBSTANTIALLY EQUIVALENT 1
APTERYX, INC.
  SUBSTANTIALLY EQUIVALENT 1
ARTERYS INC.
  SUBSTANTIALLY EQUIVALENT 5
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 1
AXON MEDICAL TECHNOLOGIES CORP.
  SUBSTANTIALLY EQUIVALENT 1
BIOBOT SURGICAL PTE LTD
  SUBSTANTIALLY EQUIVALENT 1
BLACKFORD ANALYSIS
  SUBSTANTIALLY EQUIVALENT 1
BRAINLAB AG
  SUBSTANTIALLY EQUIVALENT 4
BRAINREADER APS
  SUBSTANTIALLY EQUIVALENT 1
CALGARY SCIENTIFIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
CANON MEDICAL SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
CARESTREAM DENTAL LLC
  SUBSTANTIALLY EQUIVALENT 2
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 2
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 2
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
ECHO PIXEL INC.
  SUBSTANTIALLY EQUIVALENT 1
ECHOPIXEL INC.
  SUBSTANTIALLY EQUIVALENT 2
EIGEN
  SUBSTANTIALLY EQUIVALENT 2
EOS IMAGING
  SUBSTANTIALLY EQUIVALENT 1
EV3 INC.
  SUBSTANTIALLY EQUIVALENT 1
EWOO SOFT CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
EXINI DIAGNOSTICS AB
  SUBSTANTIALLY EQUIVALENT 1
EXOCAD GMBH
  SUBSTANTIALLY EQUIVALENT 1
FOCAL HEALTHCARE INC.
  SUBSTANTIALLY EQUIVALENT 1
FUJIFILM CORPORATION
  SUBSTANTIALLY EQUIVALENT 9
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 9
GE MEDICAL SYSTEMS, SCS
  SUBSTANTIALLY EQUIVALENT 1
GENERAL ELECTRIC CO.
  SUBSTANTIALLY EQUIVALENT 10
HDX WILL CORP.
  SUBSTANTIALLY EQUIVALENT 2
HEALTHMYNE, INC.
  SUBSTANTIALLY EQUIVALENT 1
HEART IMAGING TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
HECTEC GMBH
  SUBSTANTIALLY EQUIVALENT 2
HEPATIQ LLC
  SUBSTANTIALLY EQUIVALENT 1
HICAT GMBH
  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 2
INTUITIVE SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
INVIVO
  SUBSTANTIALLY EQUIVALENT 4
ISCHEMAVIEW, INC.
  SUBSTANTIALLY EQUIVALENT 2
KONICA MINOLTA, INC.
  SUBSTANTIALLY EQUIVALENT 4
LEXMARK ENTERPRISE SOFTWARE
  SUBSTANTIALLY EQUIVALENT 1
LG ELECTRONICS
  SUBSTANTIALLY EQUIVALENT 1
LIFETRACK MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
LK CONSULTING GROUP USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
MATERIALISE N.V.
  SUBSTANTIALLY EQUIVALENT 1
MCKESSON
  SUBSTANTIALLY EQUIVALENT 1
MCKESSON MEDICAL IMAGING COMPANY
  SUBSTANTIALLY EQUIVALENT 2
MEDCOM GMBH
  SUBSTANTIALLY EQUIVALENT 2
MEDIA LAB S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
MEDICREA INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 2
MEDIS HOLDING B.V.
  SUBSTANTIALLY EQUIVALENT 1
MEDSYNAPTIC PRIVATE, LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  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
MINT MEDICAL GMBH
  SUBSTANTIALLY EQUIVALENT 1
NEUWAVE MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
NOBEL BIOCARE
  SUBSTANTIALLY EQUIVALENT 3
NOBEL BIOCARE AB
  SUBSTANTIALLY EQUIVALENT 3
NORDICNEUROLAB AS
  SUBSTANTIALLY EQUIVALENT 1
NOVARAD CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
NUCLEUSHEALTH, LLC
  SUBSTANTIALLY EQUIVALENT 1
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
OSKO, INC.
  SUBSTANTIALLY EQUIVALENT 1
PALODEX GROUP OY
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 4
PHILIPS MEDICAL SYSTEMS INTERNATIONAL BV
  SUBSTANTIALLY EQUIVALENT 13
PHILIPS MEDICAL SYSTEMS NEDERLANDS B.V.
  SUBSTANTIALLY EQUIVALENT 1
PICOFEMTO LLC
  SUBSTANTIALLY EQUIVALENT 1
PIE MEDICAL IMAGING B.V.
  SUBSTANTIALLY EQUIVALENT 4
PLANMECA OY
  SUBSTANTIALLY EQUIVALENT 1
QI IMAGING, LLC
  SUBSTANTIALLY EQUIVALENT 3
QUANTIB BV
  SUBSTANTIALLY EQUIVALENT 4
QUANTITATIVE INSIGHTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
RAYENCE CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
REALCLOUD IMAGING INC.
  SUBSTANTIALLY EQUIVALENT 1
SAMSUNG MEDISON CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SAMSUNG MEDISON CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SICAT GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS
  SUBSTANTIALLY EQUIVALENT 16
SIEMENS AG/SIEMENS HEALTHCARE GMBH
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS CAPITAL
  SUBSTANTIALLY EQUIVALENT 12
SIEMENS HEALTHCARE GMBH
  SUBSTANTIALLY EQUIVALENT 6
SIEMENS MEDICAL SOLUTION USA, INC.
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS MEDICAL SOLUTIONS USA, INC
  SUBSTANTIALLY EQUIVALENT 4
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
THERENVA SAS
  SUBSTANTIALLY EQUIVALENT 1
TOMTEC IMAGING SYSTEMS GMBH
  SUBSTANTIALLY EQUIVALENT 1
TOSHIBA
  SUBSTANTIALLY EQUIVALENT 3
TOSHIBA MEDICAL SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
TROPHY
  SUBSTANTIALLY EQUIVALENT 2
UC-CARE LTD.
  SUBSTANTIALLY EQUIVALENT 2
VARIAN
  SUBSTANTIALLY EQUIVALENT 1
VARIAN MEDICAL SYSTEMS, INC
  SUBSTANTIALLY EQUIVALENT 1
VIDAR SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
VIDISTAR, LLC
  SUBSTANTIALLY EQUIVALENT 1
VIEWORKS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
VIRTUAL RADIOLOGIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
VISAGE IMAGING GMBH
  SUBSTANTIALLY EQUIVALENT 1
VISUAL MEDICA
  SUBSTANTIALLY EQUIVALENT 1
VISUS HEALTH IT GMBH
  SUBSTANTIALLY EQUIVALENT 2
VISUS TECHNOLOGY TRANSFER GMBH
  SUBSTANTIALLY EQUIVALENT 2
VITAL IMAGES, INC.
  SUBSTANTIALLY EQUIVALENT 6
VOLPARA HEALTH TECHNOLOGIES LIMITED
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Computer Software Problem 151
Data Problem 114
Loss of Data 114
Use of Device Problem 66
Patient Data Problem 47
Device Operates Differently Than Expected 44
Device Issue 38
Adverse Event Without Identified Device or Use Problem 31
Device Operational Issue 19
Computer Operating System Problem 12
Incorrect Measurement 10
Application Program Problem 9
Improper or Incorrect Procedure or Method 9
Overheating of Device 8
Device Inoperable 8
Smoking 8
Programming Issue 6
Application Interface Becomes Non-Functional Or Program Exits Abnormally 6
Display or Visual Feedback Problem 6
Data Back-Up Problem 5
Image Display Error / Artifact 5
Incorrect, Inadequate or Imprecise Result or Readings 4
User Interface 4
Insufficient Information 4
Patient-Device Incompatibility 4
Decoder 4
Poor Quality Image 3
Structural Problem 3
Device Displays Incorrect Message 3
Output Problem 3
No Apparent Adverse Event 3
No Display / Image 3
Appropriate Term/Code Not Available 3
Missing Test Results 3
Image Orientation Incorrect 3
Failure to Power Up 3
Human Factors Issue 2
Positioning Problem 2
Inadequacy of Device Shape and/or Size 2
Fitting Problem 2
Malposition of device 2
Nonstandard device 2
Difficult To Position 2
Failure to Back-Up 2
Incorrect Software Programming Calculations 2
Display Difficult to Read 2
Electrical /Electronic Property Problem 1
Material Fragmentation 1
Failure to Convert to Back-Up 1
Off-Label Use 1
Human-Device Interface Problem 1
Device Slipped 1
Incorrect Or Inadequate Test Results 1
Entrapment of Device 1
Fracture 1
Image Resolution Poor 1
Erratic or Intermittent Display 1
Electrical Shorting 1
Defective Device 1
Device Stops Intermittently 1
Electrical Power Problem 1
Installation-Related Problem 1
Viewer 1
Improper Device Output 1
Facilities Issue 1
Device Handling Problem 1
Device Dislodged or Dislocated 1
Material Deformation 1
Problem with Software Installation 1
Compatibility Problem 1
Operating System Becomes Nonfunctional 1
No Visual Prompts / Feedback 1
Application Program Version or Upgrade Problem 1
Migration or Expulsion of Device 1
Loss of Power 1
Total Device Problems 815

Recalls
Manufacturer Recall Class Date Posted
1 AGFA Healthcare Corp. II Jun-29-2017
2 AGFA Healthcare Corp. II Nov-17-2015
3 AGFA Healthcare Corp. II Jul-13-2015
4 AS Software, Inc. II Oct-16-2018
5 Agfa Healthcare NV II Oct-11-2018
6 Brainlab AG II Nov-05-2015
7 Carestream Health Inc II May-02-2016
8 DICOM GRID INC II Jan-18-2017
9 EOS Imaging II Sep-18-2018
10 Fujifilm Medical Systems U.S.A., Inc. II Oct-12-2016
11 Fujifilm Medical Systems U.S.A., Inc. II Jun-21-2016
12 GE Healthcare II Jun-06-2018
13 GE Healthcare II Apr-03-2018
14 GE Healthcare II Nov-05-2015
15 GE Healthcare II Oct-05-2015
16 GE Healthcare II Aug-27-2015
17 GE Healthcare II Feb-26-2015
18 GE Healthcare It II Aug-17-2016
19 GE Healthcare, LLC II Jan-17-2020
20 GE Healthcare, LLC II Jul-01-2019
21 GE Healthcare, LLC II Jun-26-2019
22 GE Healthcare, LLC II Jun-13-2019
23 GE Healthcare, LLC II Feb-01-2019
24 GE Healthcare, LLC II Dec-19-2018
25 GE Healthcare, LLC II Nov-02-2018
26 GE Healthcare, LLC II Oct-18-2018
27 GE Healthcare, LLC II Dec-23-2016
28 Ge Healthcare It II Jul-28-2016
29 Ge Medical Systems Information T II Apr-11-2017
30 Immersivetouch Inc III May-18-2020
31 Invivo Corporation II Apr-02-2018
32 Koios Medical, Inc. II Jan-17-2020
33 Konica Minolta Medical Imaging USA, Inc. II Jun-22-2018
34 Mckesson Medical Imaging II Mar-02-2017
35 Mckesson Medical Imaging Group II Sep-22-2016
36 Mckesson Medical Immaging II Mar-17-2016
37 Medtronic Navigation, Inc. II Sep-26-2018
38 Merge Healthcare, Inc. II Jul-23-2019
39 Merge Healthcare, Inc. II Oct-11-2018
40 Merge Healthcare, Inc. II Aug-18-2017
41 Merge Healthcare, Inc. II Jun-22-2017
42 Merge Healthcare, Inc. II Jun-16-2017
43 Merge Healthcare, Inc. II Jun-15-2017
44 Merge Healthcare, Inc. II Jun-15-2017
45 Merge Healthcare, Inc. II May-22-2017
46 Merge Healthcare, Inc. II Mar-21-2017
47 Merge Healthcare, Inc. II Mar-20-2017
48 Merge Healthcare, Inc. II Mar-19-2017
49 Merge Healthcare, Inc. II Mar-09-2017
50 Merge Healthcare, Inc. II Mar-09-2017
51 Merge Healthcare, Inc. II Mar-08-2017
52 Merge Healthcare, Inc. II Mar-03-2017
53 Merge Healthcare, Inc. II Mar-02-2017
54 Merge Healthcare, Inc. II Feb-09-2017
55 Merge Healthcare, Inc. II Feb-09-2017
56 Merge Healthcare, Inc. II Jan-19-2017
57 Merge Healthcare, Inc. II Dec-30-2016
58 Merge Healthcare, Inc. II Dec-21-2016
59 Merge Healthcare, Inc. II Dec-09-2016
60 Merge Healthcare, Inc. II Dec-09-2016
61 Merge Healthcare, Inc. II Dec-08-2016
62 Merge Healthcare, Inc. II Dec-05-2016
63 Merge Healthcare, Inc. II Nov-18-2016
64 Merge Healthcare, Inc. II Nov-17-2016
65 Merge Healthcare, Inc. II Nov-17-2016
66 Merge Healthcare, Inc. II Oct-20-2016
67 Merge Healthcare, Inc. II Oct-19-2016
68 Merge Healthcare, Inc. II Oct-18-2016
69 Merge Healthcare, Inc. II Sep-22-2016
70 Merge Healthcare, Inc. II Sep-21-2016
71 Merge Healthcare, Inc. II Sep-14-2016
72 Merge Healthcare, Inc. II Sep-02-2016
73 Merge Healthcare, Inc. II Sep-01-2016
74 Merge Healthcare, Inc. II Aug-29-2016
75 Merge Healthcare, Inc. II Aug-23-2016
76 Merge Healthcare, Inc. II Aug-16-2016
77 Merge Healthcare, Inc. II Aug-12-2016
78 Merge Healthcare, Inc. II Aug-10-2016
79 Merge Healthcare, Inc. II Aug-08-2016
80 Merge Healthcare, Inc. II Jul-29-2016
81 Merge Healthcare, Inc. II Jul-29-2016
82 Merge Healthcare, Inc. II Jul-11-2016
83 Merge Healthcare, Inc. II Jul-08-2016
84 Merge Healthcare, Inc. II Feb-10-2016
85 Merge Healthcare, Inc. II Dec-28-2015
86 NordicNeuroLab AS II Jun-04-2018
87 NordicNeuroLab AS II Jun-01-2018
88 NordicNeuroLab AS II Jun-01-2018
89 NordicNeuroLab AS II May-31-2018
90 NordicNeuroLab AS II May-31-2018
91 Novarad Corporation II Aug-25-2016
92 Novarad Corporation II Jul-11-2016
93 Novarad Corporation II May-06-2016
94 Ortho Kinematics, Inc II Aug-22-2018
95 Ortho Kinematics, Inc II Aug-22-2018
96 Ortho Kinematics, Inc II Aug-22-2018
97 Ortho Kinematics, Inc II Aug-21-2018
98 Philips Electronics North America Corporation II Aug-29-2016
99 Philips Ultrasound, Inc. II Jun-15-2015
100 Siemens Medical Solutions USA, Inc II May-09-2018
101 Siemens Medical Solutions USA, Inc II May-07-2018
102 Siemens Medical Solutions USA, Inc II Mar-28-2018
103 Siemens Medical Solutions USA, Inc II Mar-20-2018
104 Siemens Medical Solutions USA, Inc II Mar-01-2018
105 Siemens Medical Solutions USA, Inc II Feb-05-2018
106 Siemens Medical Solutions USA, Inc II Jan-31-2018
107 Siemens Medical Solutions USA, Inc II Nov-21-2017
108 Siemens Medical Solutions USA, Inc II Mar-27-2017
109 Siemens Medical Solutions USA, Inc II Mar-10-2017
110 Siemens Medical Solutions USA, Inc II Jan-31-2017
111 Siemens Medical Solutions USA, Inc II Sep-27-2016
112 Siemens Medical Solutions USA, Inc II Sep-21-2016
113 Siemens Medical Solutions USA, Inc II Sep-14-2016
114 Siemens Medical Solutions USA, Inc II Jul-20-2016
115 Siemens Medical Solutions USA, Inc II Jun-30-2016
116 Siemens Medical Solutions USA, Inc II Jun-29-2016
117 Siemens Medical Solutions USA, Inc II May-04-2016
118 Siemens Medical Solutions USA, Inc II Apr-07-2016
119 Siemens Medical Solutions USA, Inc II Mar-23-2016
120 Siemens Medical Solutions USA, Inc II Mar-17-2016
121 Siemens Medical Solutions USA, Inc II Feb-23-2016
122 Siemens Medical Solutions USA, Inc II Feb-19-2016
123 Siemens Medical Solutions USA, Inc II Jan-06-2016
124 Siemens Medical Solutions USA, Inc II Dec-24-2015
125 Siemens Medical Solutions USA, Inc II Nov-20-2015
126 Siemens Medical Solutions USA, Inc II Sep-02-2015
127 Siemens Medical Solutions USA, Inc II Jul-02-2015
128 Siemens Medical Solutions USA, Inc II Jun-03-2015
129 Siemens Medical Solutions USA, Inc II Mar-30-2015
130 Siemens Medical Solutions USA, Inc II Jan-28-2015
131 Siemens Medical Solutions USA, Inc. II Jan-23-2018
132 Synaptive Medical Inc II Apr-22-2020
133 TeraRecon, Inc. II Feb-09-2015
134 Zimmer Biomet, Inc. II Mar-13-2017
135 iCAD, Inc. II Mar-04-2015

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