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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)
Regulation Description Stationary x-ray system.
Product CodeMQB
Regulation Number 892.1680
Device Class 2


Premarket Reviews
ManufacturerDecision
A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
AGFA HEALTHCARE N.V.
  SUBSTANTIALLY EQUIVALENT 2
AGFA N.V.
  SUBSTANTIALLY EQUIVALENT 1
ASTEL INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOKINEMETRICS INC.
  SUBSTANTIALLY EQUIVALENT 3
BONTECH CO. LTD
  SUBSTANTIALLY EQUIVALENT 1
BONTECH INC.
  SUBSTANTIALLY EQUIVALENT 3
CANON INC.
  SUBSTANTIALLY EQUIVALENT 3
CANON, INC
  SUBSTANTIALLY EQUIVALENT 2
CANON, INC.
  SUBSTANTIALLY EQUIVALENT 3
CANON, INC. – MEDICAL EQUIPMENT GROUP
  SUBSTANTIALLY EQUIVALENT 1
CARERAY DIGITAL MEDICAL SYSTEM CO., LTD.
  SUBSTANTIALLY EQUIVALENT 6
CARESTREAM HEALTH
  SUBSTANTIALLY EQUIVALENT 2
CARESTREAM HEALTH, INC
  SUBSTANTIALLY EQUIVALENT 1
CARESTREAM HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 5
DENTIUM CO., LTD (ICT BRANCH)
  SUBSTANTIALLY EQUIVALENT 1
DRTECH CORPORATION
  SUBSTANTIALLY EQUIVALENT 6
FIRST SOURCE, INC.
  SUBSTANTIALLY EQUIVALENT 1
FUJIFILM CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
  SUBSTANTIALLY EQUIVALENT 2
H&ABYZ
  SUBSTANTIALLY EQUIVALENT 1
H&ABYZ CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
IMAGING DYNAMICS COMPANY LTD.
  SUBSTANTIALLY EQUIVALENT 4
INNOCARE OPTOELECTRONICS CORP.
  SUBSTANTIALLY EQUIVALENT 3
INNOLUX CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
IRAY TECHNOLOGY (SHANGHAI) LTD.
  SUBSTANTIALLY EQUIVALENT 1
IRAY TECHNOLOGY TAICANG LTD.
  SUBSTANTIALLY EQUIVALENT 10
JPI HEALTHCARE, INC
  SUBSTANTIALLY EQUIVALENT 1
KA IMAGING INC.
  SUBSTANTIALLY EQUIVALENT 1
KONICA MINOLTA, INC
  SUBSTANTIALLY EQUIVALENT 1
KONICA MINOLTA, INC.
  SUBSTANTIALLY EQUIVALENT 5
LED DENTAL INC
  SUBSTANTIALLY EQUIVALENT 1
LG ELECTRONICS
  SUBSTANTIALLY EQUIVALENT 1
LG ELECTRONICS INC.
  SUBSTANTIALLY EQUIVALENT 2
LIVERMORETECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDIEN INTERNATIONAL CO LTD
  SUBSTANTIALLY EQUIVALENT 1
NEUROLOGICA CORPORATION, A SUBSIDIARY OF
  SUBSTANTIALLY EQUIVALENT 1
OSKO, INC.
  SUBSTANTIALLY EQUIVALENT 3
PERKINELMER, INC.
  SUBSTANTIALLY EQUIVALENT 2
PHILIPS MEDICAL SYSTEMS DMC GMBH
  SUBSTANTIALLY EQUIVALENT 4
PIXXGEN CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
PZMEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
RADISEN INC.
  SUBSTANTIALLY EQUIVALENT 1
RADMEDIX LLC
  SUBSTANTIALLY EQUIVALENT 2
RAYENCE CO., LTD
  SUBSTANTIALLY EQUIVALENT 7
RAYENCE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SAMSUNG ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI PZ MEDICAL TECHNOLGOY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TELEVERE SYSTEMS
  SUBSTANTIALLY EQUIVALENT 2
VAREX IMAGING CORPORATION
  SUBSTANTIALLY EQUIVALENT 6
VARIAN MEDICAL SYSTEMS, X-RAY PRODUCTS-INFIMED
  SUBSTANTIALLY EQUIVALENT 1
VIEWORKS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
VIEWORKS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 5
VIZTEK LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 26 26
2017 20 20
2018 84 84
2019 45 45
2020 9 9
2021 22 22

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

Patient Problems MDRs with this Patient Problem Events in those MDRs
Radiation Exposure, Unintended 82 82
No Known Impact Or Consequence To Patient 49 49
No Consequences Or Impact To Patient 21 21
No Clinical Signs, Symptoms or Conditions 17 17
No Patient Involvement 12 12
Bone Fracture(s) 5 5
Injury 5 5
Death 3 3
No Information 2 2
Abrasion 2 2
Fall 2 2
Hematoma 1 1
Concussion 1 1
Erythema 1 1
Hip Fracture 1 1
Skin Tears 1 1
Ambulation Difficulties 1 1
No Code Available 1 1
Bruise/Contusion 1 1
Ecchymosis 1 1
Suture Abrasion 1 1
Head Injury 1 1
Hemorrhage/Bleeding 1 1
Laceration(s) 1 1
Pain 1 1
Shock 1 1

Recalls
Manufacturer Recall Class Date Posted
1 AGFA Healthcare Corp. II Jul-14-2017
2 Canon Medical System, USA, INC. II Mar-17-2021
3 Canon Medical System, USA, INC. II Mar-09-2021
4 Canon Medical System, USA, INC. II Jun-09-2020
5 Canon Medical System, USA, INC. II Nov-12-2019
6 Canon Medical System, USA, INC. II Jul-11-2019
7 Canon Medical System, USA, INC. II Aug-31-2018
8 Konica Minolta Medical Imaging USA, Inc. II Jun-22-2018
9 LIEBEL-FLARSHEIM COMPANY LLC II Jul-02-2021
10 LIEBEL-FLARSHEIM COMPANY LLC II Aug-21-2018
11 NeuroLogica Corporation II Apr-17-2018
12 Palodex Group Oy II Jan-24-2020
13 Philips Electronics North America Corporation II Feb-23-2018
14 Philips Electronics North America Corporation II Jun-09-2017
15 Philips Healthcare II Jun-03-2016
16 Philips Medical Systems Gmbh, DMC II Oct-24-2018
17 Philips Medical Systems Gmbh, DMC II Aug-17-2018
18 Sedecal S.A. II Nov-20-2018
19 Siemens Medical Solutions USA, Inc II May-05-2020
20 Swissray Medical AG II Jan-08-2019
21 Toshiba American Medical Systems II Sep-11-2017
22 Virtual Imaging, Inc. II Nov-14-2018
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