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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 2
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 3
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
ECHOPIXEL, INC.
  SUBSTANTIALLY EQUIVALENT 1
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 10
GE MEDICAL SYSTEMS, SCS
  SUBSTANTIALLY EQUIVALENT 1
GENERAL ELECTRIC CO.
  SUBSTANTIALLY EQUIVALENT 11
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
MIRADA MEDICAL LTD
  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 5
PHILIPS MEDICAL SYSTEMS INTERNATIONAL BV
  SUBSTANTIALLY EQUIVALENT 15
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 5
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 19
SIEMENS AG/SIEMENS HEALTHCARE GMBH
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS CAPITAL
  SUBSTANTIALLY EQUIVALENT 15
SIEMENS HEALTHCARE GMBH
  SUBSTANTIALLY EQUIVALENT 7
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

MDR Year MDR Reports MDR Events
2015 210 210
2016 290 290
2017 104 104
2018 72 72
2019 88 88
2020 51 51

Device Problems MDRs with this Device Problem Events in those MDRs
Computer Software Problem 273 273
Loss of Data 127 127
Data Problem 122 122
Nonstandard Device 114 114
Use of Device Problem 70 70
Device Operates Differently Than Expected 66 66
Patient Data Problem 66 66
Device Issue 38 38
Adverse Event Without Identified Device or Use Problem 33 33
Device Operational Issue 19 19
Computer Operating System Problem 19 19
Application Program Problem 16 16
Improper or Incorrect Procedure or Method 14 14
Incorrect Measurement 12 12
Overheating of Device 10 10
Smoking 9 9
Programming Issue 8 8
Device Inoperable 8 8
Application Interface Becomes Non-Functional Or Program Exits Abnormally 8 8
Device Displays Incorrect Message 7 7
Data Back-Up Problem 7 7
Insufficient Information 7 7
Display or Visual Feedback Problem 7 7
Use of Incorrect Control Settings 6 6
Image Display Error/Artifact 6 6
Poor Quality Image 6 6
Image Orientation Incorrect 5 5
Failure to Power Up 5 5
Incorrect, Inadequate or Imprecise Resultor Readings 4 4
No Display/Image 4 4
No Apparent Adverse Event 4 4
Patient-Device Incompatibility 4 4
Output Problem 4 4
User Interface 4 4
Decoder 4 4
Fitting Problem 4 4
Device Stops Intermittently 4 4
Positioning Problem 4 4
Improper Device Output 3 3
Malposition of Device 3 3
Installation-Related Problem 3 3
Communication or Transmission Problem 3 3
Appropriate Term/Code Not Available 3 3
Missing Test Results 3 3
Structural Problem 3 3
Incorrect Software Programming Calculations 2 2
Incorrect Or Inadequate Test Results 2 2
Keypad 2 2
Difficult To Position 2 2
Loss of Power 2 2
Break 2 2
Migration or Expulsion of Device 2 2
Human Factors Issue 2 2
Problem with Software Installation 2 2
Failure to Read Input Signal 2 2
Inadequacy of Device Shape and/or Size 2 2
Failure to Back-Up 2 2
Display Difficult to Read 2 2
Application Program Problem: Parameter Calculation Error 2 2
Unable to Obtain Readings 1 1
Material Rupture 1 1
Self-Activation or Keying 1 1
Image Resolution Poor 1 1
Kinked 1 1
Erratic or Intermittent Display 1 1
Electrical /Electronic Property Problem 1 1
Entrapment of Device 1 1
Failure to Convert to Back-Up 1 1
Intermittent Continuity 1 1
Unstable 1 1
Battery Problem 1 1
Chemical Spillage 1 1
Electrical Power Problem 1 1
Electrical Shorting 1 1
Facilities Issue 1 1
Compatibility Problem 1 1
Material Deformation 1 1
Mechanics Altered 1 1
No Visual Prompts/Feedback 1 1
Measurement System Incompatibility 1 1
Operating System Becomes Nonfunctional 1 1
Human-Device Interface Problem 1 1
Device Handling Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Viewer 1 1
Program or Algorithm Execution Failure 1 1
Mechanical Problem 1 1
Melted 1 1
No Audible Alarm 1 1
Unintended Arm Motion 1 1
False Negative Result 1 1
Fire 1 1
Fracture 1 1
Material Fragmentation 1 1
Device Slipped 1 1
Off-Label Use 1 1
Defective Device 1 1
Sparking 1 1
Application Program Version or Upgrade Problem 1 1
Difficult to Open or Close 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 625 625
No Consequences Or Impact To Patient 79 79
No Patient Involvement 40 40
No Information 29 29
Misdiagnosis 11 11
No Code Available 10 10
Death 6 6
Failure of Implant 5 5
Missing Value Reason 4 4
Pain 2 2
Radiation Exposure, Unintended 2 2
Bone Fracture(s) 2 2
Radiation Overdose 2 2
Stenosis 2 2
Aortic Valve Stenosis 2 2
Arthritis 1 1
Crushing Injury 1 1
Abscess 1 1
Anemia 1 1
Inflammation 1 1
Lupus 1 1
Perforation 1 1
Radiation Underdose 1 1
Hernia 1 1
Sinus Perforation 1 1
Ambulation Difficulties 1 1
Therapeutic Response, Increased 1 1
Discomfort 1 1
Complaint, Ill-Defined 1 1
Injury 1 1
Disability 1 1
Obstruction/Occlusion 1 1
Vascular System (Circulation), Impaired 1 1
Cardiac Arrest 1 1
Infarction, Cerebral 1 1
Liver Damage/Dysfunction 1 1
Inadequate Osseointegration 1 1
Foreign Body In Patient 1 1
Patient Problem/Medical Problem 1 1
Device Embedded In Tissue or Plaque 1 1
Not Applicable 1 1
Respiratory Distress 1 1
Seizures 1 1

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 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 II Nov-05-2015
16 GE Healthcare II Oct-05-2015
17 GE Healthcare II Aug-27-2015
18 GE Healthcare II Feb-26-2015
19 GE Healthcare It II Aug-17-2016
20 GE Healthcare, LLC II Jan-17-2020
21 GE Healthcare, LLC II Jul-01-2019
22 GE Healthcare, LLC II Jun-26-2019
23 GE Healthcare, LLC II Jun-13-2019
24 GE Healthcare, LLC II Feb-01-2019
25 GE Healthcare, LLC II Dec-19-2018
26 GE Healthcare, LLC II Nov-02-2018
27 GE Healthcare, LLC II Oct-18-2018
28 GE Healthcare, LLC II Dec-23-2016
29 Ge Healthcare It II Jul-28-2016
30 Ge Medical Systems Information T II Apr-11-2017
31 Immersivetouch Inc III May-18-2020
32 Invivo Corporation II Apr-02-2018
33 Koios Medical, Inc. II Jan-17-2020
34 Konica Minolta Medical Imaging USA, Inc. II Jun-22-2018
35 Mckesson Medical Imaging II Mar-02-2017
36 Mckesson Medical Imaging Group II Sep-22-2016
37 Mckesson Medical Immaging II Mar-17-2016
38 Medtronic Navigation, Inc. II Sep-26-2018
39 Merge Healthcare, Inc. II Sep-09-2020
40 Merge Healthcare, Inc. II Jun-19-2020
41 Merge Healthcare, Inc. II Jul-23-2019
42 Merge Healthcare, Inc. II Oct-11-2018
43 Merge Healthcare, Inc. II Aug-18-2017
44 Merge Healthcare, Inc. II Jun-22-2017
45 Merge Healthcare, Inc. II Jun-16-2017
46 Merge Healthcare, Inc. II Jun-15-2017
47 Merge Healthcare, Inc. II Jun-15-2017
48 Merge Healthcare, Inc. II May-22-2017
49 Merge Healthcare, Inc. II Mar-21-2017
50 Merge Healthcare, Inc. II Mar-20-2017
51 Merge Healthcare, Inc. II Mar-19-2017
52 Merge Healthcare, Inc. II Mar-09-2017
53 Merge Healthcare, Inc. II Mar-09-2017
54 Merge Healthcare, Inc. II Mar-08-2017
55 Merge Healthcare, Inc. II Mar-03-2017
56 Merge Healthcare, Inc. II Mar-02-2017
57 Merge Healthcare, Inc. II Feb-09-2017
58 Merge Healthcare, Inc. II Feb-09-2017
59 Merge Healthcare, Inc. II Jan-19-2017
60 Merge Healthcare, Inc. II Dec-30-2016
61 Merge Healthcare, Inc. II Dec-21-2016
62 Merge Healthcare, Inc. II Dec-09-2016
63 Merge Healthcare, Inc. II Dec-09-2016
64 Merge Healthcare, Inc. II Dec-08-2016
65 Merge Healthcare, Inc. II Dec-05-2016
66 Merge Healthcare, Inc. II Nov-18-2016
67 Merge Healthcare, Inc. II Nov-17-2016
68 Merge Healthcare, Inc. II Nov-17-2016
69 Merge Healthcare, Inc. II Oct-20-2016
70 Merge Healthcare, Inc. II Oct-19-2016
71 Merge Healthcare, Inc. II Oct-18-2016
72 Merge Healthcare, Inc. II Sep-22-2016
73 Merge Healthcare, Inc. II Sep-21-2016
74 Merge Healthcare, Inc. II Sep-14-2016
75 Merge Healthcare, Inc. II Sep-02-2016
76 Merge Healthcare, Inc. II Sep-01-2016
77 Merge Healthcare, Inc. II Aug-29-2016
78 Merge Healthcare, Inc. II Aug-23-2016
79 Merge Healthcare, Inc. II Aug-16-2016
80 Merge Healthcare, Inc. II Aug-12-2016
81 Merge Healthcare, Inc. II Aug-10-2016
82 Merge Healthcare, Inc. II Aug-08-2016
83 Merge Healthcare, Inc. II Jul-29-2016
84 Merge Healthcare, Inc. II Jul-29-2016
85 Merge Healthcare, Inc. II Jul-11-2016
86 Merge Healthcare, Inc. II Jul-08-2016
87 Merge Healthcare, Inc. II Feb-10-2016
88 Merge Healthcare, Inc. II Dec-28-2015
89 NordicNeuroLab AS II Jun-04-2018
90 NordicNeuroLab AS II Jun-01-2018
91 NordicNeuroLab AS II Jun-01-2018
92 NordicNeuroLab AS II May-31-2018
93 NordicNeuroLab AS II May-31-2018
94 Novarad Corporation II Sep-12-2020
95 Novarad Corporation II Aug-25-2016
96 Novarad Corporation II Jul-11-2016
97 Novarad Corporation II May-06-2016
98 Ortho Kinematics, Inc II Aug-22-2018
99 Ortho Kinematics, Inc II Aug-22-2018
100 Ortho Kinematics, Inc II Aug-22-2018
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