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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
A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
AGFA N.V.
  SUBSTANTIALLY EQUIVALENT 2
ALLENGERS MEDICAL SYSTEMS LIMITED
  SUBSTANTIALLY EQUIVALENT 1
ASTEL INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOKINEMETRICS INC.
  SUBSTANTIALLY EQUIVALENT 3
BONTECH CO. LTD
  SUBSTANTIALLY EQUIVALENT 1
CANON INC.
  SUBSTANTIALLY EQUIVALENT 10
CANON, INC.
  SUBSTANTIALLY EQUIVALENT 3
CARERAY DIGITAL MEDICAL SYSTEM CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
CARERAY DIGITAL MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
CARESTREAM HEALTH
  SUBSTANTIALLY EQUIVALENT 1
CARESTREAM HEALTH, INC
  SUBSTANTIALLY EQUIVALENT 1
CARESTREAM HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 6
DENTIUM CO., LTD (ICT BRANCH)
  SUBSTANTIALLY EQUIVALENT 1
DRTECH CORPORATION
  SUBSTANTIALLY EQUIVALENT 6
FIRST SOURCE, INC.
  SUBSTANTIALLY EQUIVALENT 1
FUJIFILM CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
H&ABYZ
  SUBSTANTIALLY EQUIVALENT 1
H&ABYZ CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
INNOCARE OPTOELECTRONICS CORP.
  SUBSTANTIALLY EQUIVALENT 4
IRAY TECHNOLOGY TAICANG LTD.
  SUBSTANTIALLY EQUIVALENT 17
KA IMAGING INC.
  SUBSTANTIALLY EQUIVALENT 1
KONICA MINOLTA HEALTHCARE AMERICAS, INC.
  SUBSTANTIALLY EQUIVALENT 1
KONICA MINOLTA, INC.
  SUBSTANTIALLY EQUIVALENT 5
LG ELECTRONICS
  SUBSTANTIALLY EQUIVALENT 1
LG ELECTRONICS INC.
  SUBSTANTIALLY EQUIVALENT 8
LIVERMORETECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDICATECH USA
  SUBSTANTIALLY EQUIVALENT 1
OSKO, INC.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS DMC GMBH
  SUBSTANTIALLY EQUIVALENT 2
PIXXGEN CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
PZMEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
RADISEN CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
RADISEN INC.
  SUBSTANTIALLY EQUIVALENT 1
RADMEDIX LLC
  SUBSTANTIALLY EQUIVALENT 3
RAY IMAGING TECHNOLOGY (HAINING) LIMITED
  SUBSTANTIALLY EQUIVALENT 1
RAYENCE CO., LTD
  SUBSTANTIALLY EQUIVALENT 4
RAYENCE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SAMSUNG ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
VAREX IMAGING CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
VIEWORKS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 5

MDR Year MDR Reports MDR Events
2018 84 84
2019 45 45
2020 9 9
2021 26 26
2022 13 13
2023 47 47

Device Problems MDRs with this Device Problem Events in those MDRs
Device Operational Issue 80 80
Device Fell 39 39
Device Handling Problem 35 35
Detachment of Device or Device Component 35 35
Poor Quality Image 12 12
Break 9 9
Unintended Movement 5 5
Misassembly During Maintenance/Repair 4 4
Output Problem 4 4
No Display/Image 4 4
Use of Device Problem 4 4
Image Display Error/Artifact 3 3
Failure to Align 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Defective Component 2 2
Radiation Overexposure 2 2
Misassembled During Installation 2 2
Defective Device 2 2
Loose or Intermittent Connection 2 2
Improper or Incorrect Procedure or Method 2 2
Fire 2 2
Unintended System Motion 2 2
Failure to Power Up 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
Smoking 1 1
Device Inoperable 1 1
False Alarm 1 1
Display or Visual Feedback Problem 1 1
Detachment Of Device Component 1 1
Component Falling 1 1
Computer Software Problem 1 1
Fitting Problem 1 1
Nonstandard Device 1 1
Mechanical Problem 1 1
Image Reversal 1 1
Device Displays Incorrect Message 1 1
Malposition of Device 1 1
Patient-Device Incompatibility 1 1
Battery Problem 1 1
Charging Problem 1 1
Communication or Transmission Problem 1 1
Failure to Advance 1 1
Device Operates Differently Than Expected 1 1
Radiation Output Problem 1 1
Appropriate Term/Code Not Available 1 1
Sharp Edges 1 1
Therapeutic or Diagnostic Output Failure 1 1
Device Dislodged or Dislocated 1 1
Installation-Related Problem 1 1
Material Integrity Problem 1 1
Material Twisted/Bent 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Radiation Exposure, Unintended 81 81
No Clinical Signs, Symptoms or Conditions 73 73
No Known Impact Or Consequence To Patient 23 23
No Consequences Or Impact To Patient 18 18
No Patient Involvement 10 10
Bone Fracture(s) 5 5
Injury 3 3
Laceration(s) 3 3
Damage to Ligament(s) 2 2
Pain 1 1
Shock 1 1
Concussion 1 1
Abrasion 1 1
Bruise/Contusion 1 1
Eye Injury 1 1
Fall 1 1
Hip Fracture 1 1
Skin Tears 1 1
Ambulation Difficulties 1 1
Hair Loss 1 1
Head Injury 1 1
Unspecified Eye / Vision Problem 1 1
Unintended Radiation Exposure 1 1
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Canon Medical System, USA, INC. II Mar-17-2021
2 Canon Medical System, USA, INC. II Mar-09-2021
3 Canon Medical System, USA, INC. II Jun-09-2020
4 Canon Medical System, USA, INC. II Nov-12-2019
5 Canon Medical System, USA, INC. II Jul-11-2019
6 Canon Medical System, USA, INC. II Aug-31-2018
7 Konica Minolta Medical Imaging USA, Inc. II Jun-22-2018
8 LIEBEL-FLARSHEIM COMPANY LLC II Jul-02-2021
9 LIEBEL-FLARSHEIM COMPANY LLC II Aug-21-2018
10 NeuroLogica Corporation II Apr-17-2018
11 Palodex Group Oy II Jan-24-2020
12 Philips Electronics North America Corporation II Feb-23-2018
13 Philips Healthcare II Nov-24-2021
14 Philips Medical Systems Gmbh, DMC II Oct-24-2018
15 Philips Medical Systems Gmbh, DMC II Aug-17-2018
16 Philips North America Llc II Jun-30-2023
17 Sedecal S.A. II Nov-20-2018
18 Siemens Medical Solutions USA, Inc II May-05-2020
19 Swissray Medical AG II Jan-08-2019
20 Virtual Imaging, Inc. II Nov-14-2018
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