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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device solid state x-ray imager (flat panel/digital imager)
Product CodeMQB
Regulation Number 892.1680
Device Class 2


Premarket Reviews
ManufacturerDecision
2020 IMAGING
  SUBSTANTIALLY EQUIVALENT 1
3DISC AMERICAS
  SUBSTANTIALLY EQUIVALENT 3
5 STAR MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
ABYZR CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
AGFA HEALTHCARE N.V.
  SUBSTANTIALLY EQUIVALENT 13
AGFA N.V.
  SUBSTANTIALLY EQUIVALENT 2
AIR TECHNIQUES, INC.
  SUBSTANTIALLY EQUIVALENT 1
ALARA, INC.
  SUBSTANTIALLY EQUIVALENT 1
ALLENGERS MEDICAL SYSTEMS LIMITED
  SUBSTANTIALLY EQUIVALENT 1
ALMANA MEDICAL IMAGING
  SUBSTANTIALLY EQUIVALENT 1
ASTEL INC.
  SUBSTANTIALLY EQUIVALENT 1
ATLAIM
  SUBSTANTIALLY EQUIVALENT 1
ATLAIM CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
BIOKINEMETRICS INC.
  SUBSTANTIALLY EQUIVALENT 3
BONTECH CO. LTD
  SUBSTANTIALLY EQUIVALENT 1
BONTECH INC.
  SUBSTANTIALLY EQUIVALENT 3
CANON INC.
  SUBSTANTIALLY EQUIVALENT 13
CANON U.S.A., INC.
  SUBSTANTIALLY EQUIVALENT 1
CANON, INC
  SUBSTANTIALLY EQUIVALENT 2
CANON, INC.
  SUBSTANTIALLY EQUIVALENT 6
CANON, INC. – MEDICAL EQUIPMENT GROUP
  SUBSTANTIALLY EQUIVALENT 1
CANON, INC.-MEDICAL EQUIPMENT GROUP
  SUBSTANTIALLY EQUIVALENT 5
CARERAY DIGITAL MEDICAL SYSTEM CO., LTD.
  SUBSTANTIALLY EQUIVALENT 10
CARERAY DIGITAL MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
CARESTREAM HEALTH
  SUBSTANTIALLY EQUIVALENT 2
CARESTREAM HEALTH, INC
  SUBSTANTIALLY EQUIVALENT 1
CARESTREAM HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 11
CARESTREAM HEALTH,INC.
  SUBSTANTIALLY EQUIVALENT 1
COMED CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
COMMUNICATIONS & POWER INDUSTRIES CANADA, INC.
  SUBSTANTIALLY EQUIVALENT 1
DEL MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
DENTIUM CO., LTD (ICT BRANCH)
  SUBSTANTIALLY EQUIVALENT 1
DIRECT DIGITAL IMAGING TECHNOLOGY (BEIJING) INC
  SUBSTANTIALLY EQUIVALENT 2
DRTECH CORP.
  SUBSTANTIALLY EQUIVALENT 3
DRTECH CORPORATION
  SUBSTANTIALLY EQUIVALENT 12
E-WOO TECHNOLOGY
  SUBSTANTIALLY EQUIVALENT 1
EOS IMAGING
  SUBSTANTIALLY EQUIVALENT 2
FIRST SOURCE, INC.
  SUBSTANTIALLY EQUIVALENT 1
FUJIFILM CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
FUJIFILM MEDICAL SYSTEM U.S.A., INC.
  SUBSTANTIALLY EQUIVALENT 6
FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
  SUBSTANTIALLY EQUIVALENT 5
FUJIFILM MEDICAL SYSTEMS USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
GE MEDICAL SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 1
H&ABYZ
  SUBSTANTIALLY EQUIVALENT 1
H&ABYZ CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
HUMANRAY CO,LTD
  SUBSTANTIALLY EQUIVALENT 1
ICRCO INC.
  SUBSTANTIALLY EQUIVALENT 2
IMAGING DYNAMICS COMPANY LTD.
  SUBSTANTIALLY EQUIVALENT 5
INNOCARE OPTOELECTRONICS CORP.
  SUBSTANTIALLY EQUIVALENT 4
INNOLUX CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
IRAY TECHNOLOGY (SHANGHAI) LTD.
  SUBSTANTIALLY EQUIVALENT 1
IRAY TECHNOLOGY TAICANG LTD.
  SUBSTANTIALLY EQUIVALENT 17
JPI HEALTHCARE CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
JPI HEALTHCARE, INC
  SUBSTANTIALLY EQUIVALENT 1
KA IMAGING INC.
  SUBSTANTIALLY EQUIVALENT 1
KONICA MINOLTA HEALTHCARE AMERICAS, INC.
  SUBSTANTIALLY EQUIVALENT 1
KONICA MINOLTA MEDICAL & GRAPHIC, INC.
  SUBSTANTIALLY EQUIVALENT 6
KONICA MINOLTA, INC
  SUBSTANTIALLY EQUIVALENT 1
KONICA MINOLTA, INC.
  SUBSTANTIALLY EQUIVALENT 9
KUB TECHNOLOGIES, INC
  SUBSTANTIALLY EQUIVALENT 2
LED DENTAL INC
  SUBSTANTIALLY EQUIVALENT 1
LG ELECTRONICS
  SUBSTANTIALLY EQUIVALENT 1
LG ELECTRONICS INC.
  SUBSTANTIALLY EQUIVALENT 8
LIEBEL-FLARSHEIM
  SUBSTANTIALLY EQUIVALENT 1
LIVERMORETECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDICATECH USA
  SUBSTANTIALLY EQUIVALENT 3
MEDIEN INTERNATIONAL CO LTD
  SUBSTANTIALLY EQUIVALENT 1
MEDIEN INTERNATIONAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
MERIDIAN MEDICAL SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 5
NEUROLOGICA CORPORATION, A SUBSIDIARY OF
  SUBSTANTIALLY EQUIVALENT 1
NEW MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
OEHM UND REHBEIN GMBH
  SUBSTANTIALLY EQUIVALENT 2
OSKO, INC.
  SUBSTANTIALLY EQUIVALENT 3
PERKINELMER, INC
  SUBSTANTIALLY EQUIVALENT 1
PERKINELMER, INC.
  SUBSTANTIALLY EQUIVALENT 4
PHILIPS MEDICAL SYSTEMS DMC GMBH
  SUBSTANTIALLY EQUIVALENT 8
PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.
  SUBSTANTIALLY EQUIVALENT 1
PIXXGEN CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
PORTAVISION MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
PZMEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
RADIOLOGY SOLUTIONS LLC
  SUBSTANTIALLY EQUIVALENT 1
RADISEN CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
RADISEN INC.
  SUBSTANTIALLY EQUIVALENT 1
RADLINK, INC.
  SUBSTANTIALLY EQUIVALENT 1
RADMEDIX LLC
  SUBSTANTIALLY EQUIVALENT 3
RAY CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
RAY IMAGING TECHNOLOGY (HAINING) LIMITED
  SUBSTANTIALLY EQUIVALENT 1
RAYENCE CO., LTD
  SUBSTANTIALLY EQUIVALENT 25
RAYENCE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SAMSUNG ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
SAMSUNG MOBILE DISPLAY CO., LTD
  SUBSTANTIALLY EQUIVALENT 5
SEDECAL SA
  SUBSTANTIALLY EQUIVALENT 2
SEHYUN CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI PZ MEDICAL TECHNOLGOY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SIMONDR, INC.
  SUBSTANTIALLY EQUIVALENT 1
SWISSRAY MEDICAL AG
  SUBSTANTIALLY EQUIVALENT 2
TELEVERE SYSTEMS
  SUBSTANTIALLY EQUIVALENT 2
TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
VAREX IMAGING CORPORATION
  SUBSTANTIALLY EQUIVALENT 6
VARIAN MEDICAL SYSTEMS, X-RAY PRODUCTS-INFIMED
  SUBSTANTIALLY EQUIVALENT 1
VATECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
VIEWORKS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
VIEWORKS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 10
VIZTEK LLC
  SUBSTANTIALLY EQUIVALENT 5

MDR Year MDR Reports MDR Events
2014 29 29
2015 21 21
2016 26 26
2017 20 20
2018 84 84
2019 45 45
2020 9 9
2021 26 26
2022 13 13
2023 51 51
2024 11 11

Device Problems MDRs with this Device Problem Events in those MDRs
Device Operational Issue 80 80
Device Fell 51 51
Device Handling Problem 46 46
Detachment of Device or Device Component 35 35
Device Operates Differently Than Expected 21 21
Poor Quality Image 18 18
Device Inoperable 11 11
Break 10 10
Component Falling 9 9
Device Displays Incorrect Message 8 8
Unintended Movement 8 8
No Display/Image 7 7
Improper or Incorrect Procedure or Method 6 6
Adverse Event Without Identified Device or Use Problem 5 5
Image Display Error/Artifact 5 5
Loose or Intermittent Connection 5 5
Mechanical Problem 5 5
Nonstandard Device 5 5
Smoking 4 4
Unintended System Motion 4 4
Output Problem 4 4
Use of Device Problem 4 4
Misassembly During Maintenance/Repair 4 4
Failure to Align 3 3
Malposition of Device 3 3
Computer Operating System Problem 3 3
No Device Output 3 3
Detachment Of Device Component 3 3
Fire 3 3
Crack 2 2
Application Interface Becomes Non-Functional Or Program Exits Abnormally 2 2
Erratic or Intermittent Display 2 2
Overheating of Device 2 2
Loss of Power 2 2
Loss of Data 2 2
Folded 2 2
Fitting Problem 2 2
Defective Component 2 2
Radiation Overexposure 2 2
Mechanical Jam 2 2
Defective Device 2 2
Appropriate Term/Code Not Available 2 2
Noise, Audible 2 2
Radiation Output Problem 2 2
Misassembled During Installation 2 2
Sharp Edges 1 1
Insufficient Information 1 1
Naturally Worn 1 1
Operating System Becomes Nonfunctional 1 1
Radiation Underexposure 1 1
Scratched Material 1 1
Therapeutic or Diagnostic Output Failure 1 1
Difficult to Open or Close 1 1
Device Dislodged or Dislocated 1 1
Electrical Shorting 1 1
Facilities Issue 1 1
Human Factors Issue 1 1
Installation-Related Problem 1 1
Material Integrity Problem 1 1
Material Twisted/Bent 1 1
Structural Problem 1 1
Failure to Advance 1 1
Misfire 1 1
Patient-Device Incompatibility 1 1
Battery Problem 1 1
Charging Problem 1 1
Communication or Transmission Problem 1 1
Failure to Power Up 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Retraction Problem 1 1
Self-Activation or Keying 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Failure to Read Input Signal 1 1
Device Slipped 1 1
Difficult To Position 1 1
Device Stops Intermittently 1 1
Unintended Collision 1 1
Computer Software Problem 1 1
Thermal Decomposition of Device 1 1
False Alarm 1 1
Signal Artifact/Noise 1 1
Display or Visual Feedback Problem 1 1
Image Reversal 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Radiation Exposure, Unintended 87 87
No Clinical Signs, Symptoms or Conditions 87 87
No Known Impact Or Consequence To Patient 69 69
No Consequences Or Impact To Patient 35 35
No Patient Involvement 14 14
Injury 8 8
Bone Fracture(s) 6 6
Laceration(s) 4 4
Death 3 3
Fall 3 3
No Information 3 3
No Code Available 3 3
Hip Fracture 2 2
Skin Tears 2 2
Abrasion 2 2
Damage to Ligament(s) 2 2
Pain 1 1
Shock 1 1
Concussion 1 1
Hair Loss 1 1
Head Injury 1 1
Hematoma 1 1
Hemorrhage/Bleeding 1 1
Bruise/Contusion 1 1
Radiation Overdose 1 1
Ecchymosis 1 1
Erythema 1 1
Eye Injury 1 1
Ambulation Difficulties 1 1
Suture Abrasion 1 1
Complaint, Ill-Defined 1 1
Unspecified Eye / Vision Problem 1 1
Unintended Radiation Exposure 1 1
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 AGFA Corp. II Mar-19-2013
2 AGFA Corp. II Feb-19-2012
3 AGFA Corp. II Jan-11-2012
4 AGFA Corp. II May-04-2011
5 AGFA Corp. II Nov-26-2010
6 AGFA Corp. II Jul-26-2010
7 AGFA Healthcare Corp. II Jul-14-2017
8 Canon Inc. II Aug-24-2012
9 Canon Medical System, USA, INC. II Mar-17-2021
10 Canon Medical System, USA, INC. II Mar-09-2021
11 Canon Medical System, USA, INC. II Jun-09-2020
12 Canon Medical System, USA, INC. II Nov-12-2019
13 Canon Medical System, USA, INC. II Jul-11-2019
14 Canon Medical System, USA, INC. II Aug-31-2018
15 Carestream Health Inc. II Nov-07-2013
16 Carestream Health, Inc. II Aug-13-2012
17 Cooper Surgical, Inc. II Apr-03-2013
18 EOS Imaging II Jan-09-2014
19 Eos Imaging Inc II May-05-2015
20 Eos Imaging Inc II Sep-28-2012
21 GE Healthcare, LLC II Feb-24-2014
22 GE Healthcare, LLC II Mar-13-2013
23 GE Healthcare, LLC II Mar-11-2013
24 GE Healthcare, LLC II Sep-13-2012
25 GE Healthcare, LLC II Oct-28-2011
26 GE Healthcare, LLC II Nov-17-2010
27 GE Healthcare, LLC II Nov-16-2010
28 GE Healthcare, LLC II Aug-19-2010
29 GE Medical Systems, LLC II Jan-13-2010
30 GE Medical Systems, LLC II Dec-16-2009
31 GE Medical Systems, LLC II Nov-09-2009
32 GE Medical Systems, LLC II Sep-24-2009
33 GE Medical Systems, LLC II Sep-24-2009
34 GE Medical Systems, LLC II Jun-19-2009
35 GE Medical Systems, LLC II May-19-2009
36 GE Medical Systems, LLC II Mar-12-2009
37 GE Medical Systems, LLC II Jan-21-2009
38 Ge Healthcare II Sep-24-2009
39 Ge Healthcare, Llc II Jun-29-2010
40 Ge Healthcare, Llc II May-26-2010
41 General Electric Med Systems LLC II Jun-08-2012
42 Konica Minolta Medical Imaging USA, Inc. II Jun-22-2018
43 LIEBEL-FLARSHEIM COMPANY LLC II Jul-02-2021
44 LIEBEL-FLARSHEIM COMPANY LLC II Aug-21-2018
45 NeuroLogica Corporation II Apr-17-2018
46 Palodex Group Oy II Jan-24-2020
47 Philips Electronics North America Corporation II Feb-23-2018
48 Philips Electronics North America Corporation II Jun-09-2017
49 Philips Electronics North America Corporation II Nov-11-2015
50 Philips Healthcare II Nov-24-2021
51 Philips Healthcare II Jun-03-2016
52 Philips Healthcare Inc. II Jun-17-2013
53 Philips Healthcare Inc. II Mar-01-2013
54 Philips Healthcare Inc. II Feb-26-2013
55 Philips Healthcare Inc. II Dec-05-2012
56 Philips Healthcare Inc. II Sep-28-2012
57 Philips Healthcare Inc. II Sep-27-2012
58 Philips Healthcare Inc. II Sep-14-2012
59 Philips Healthcare Inc. II Jun-15-2012
60 Philips Healthcare Inc. II Apr-26-2012
61 Philips Healthcare Inc. II Nov-30-2011
62 Philips Medical Systems Gmbh, DMC II Oct-24-2018
63 Philips Medical Systems Gmbh, DMC II Aug-17-2018
64 Philips Medical Systems North America Co. Phillips II Mar-23-2010
65 Philips Medical Systems, Inc. II May-19-2015
66 Philips Medical Systems, Inc. II Dec-27-2013
67 Philips North America Llc II Jun-30-2023
68 Sedecal S.A. II Nov-20-2018
69 Siemens Medical Solutions USA, Inc II May-05-2020
70 Siemens Medical Solutions USA, Inc II Jul-24-2013
71 Siemens Medical Solutions USA, Inc II Apr-09-2012
72 Siemens Medical Solutions USA, Inc II Mar-05-2012
73 Siemens Medical Solutions USA, Inc II Jan-25-2012
74 Siemens Medical Solutions USA, Inc II Jul-11-2011
75 Siemens Medical Solutions USA, Inc II Feb-23-2011
76 Siemens Medical Solutions USA, Inc II Dec-17-2010
77 Siemens Medical Solutions USA, Inc II Aug-13-2010
78 Siemens Medical Solutions USA, Inc II May-28-2010
79 Siemens Medical Solutions USA, Inc II Apr-05-2010
80 Siemens Medical Solutions USA, Inc II May-06-2009
81 Swissray Medical AG II Jan-08-2019
82 Toshiba American Medical Systems II Sep-11-2017
83 Toshiba American Medical Systems Inc II Jun-04-2014
84 Toshiba American Medical Systems Inc II Mar-25-2013
85 Toshiba American Medical Systems Inc II Feb-02-2012
86 Toshiba American Medical Systems Inc II Dec-01-2011
87 Toshiba American Medical Systems Inc II Mar-22-2010
88 Toshiba American Medical Systems Inc II Sep-28-2009
89 Virtual Imaging, Inc. II Nov-14-2018
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