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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 2
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 5
DENTIUM CO., LTD (ICT BRANCH)
  SUBSTANTIALLY EQUIVALENT 1
DRTECH CORPORATION
  SUBSTANTIALLY EQUIVALENT 7
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 15
KA IMAGING INC.
  SUBSTANTIALLY EQUIVALENT 1
KONICA MINOLTA HEALTHCARE AMERICAS, INC.
  SUBSTANTIALLY EQUIVALENT 1
KONICA MINOLTA, INC.
  SUBSTANTIALLY EQUIVALENT 4
LG ELECTRONICS INC.
  SUBSTANTIALLY EQUIVALENT 6
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 2
PZMEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
RADISEN CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
RADMEDIX LLC
  SUBSTANTIALLY EQUIVALENT 3
RAY IMAGING TECHNOLOGY (HAINING) LIMITED
  SUBSTANTIALLY EQUIVALENT 1
RAYENCE CO., LTD
  SUBSTANTIALLY EQUIVALENT 5
RAYENCE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
VAREX IMAGING CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
VIEWORKS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4

MDR Year MDR Reports MDR Events
2019 45 45
2020 9 9
2021 26 26
2022 13 13
2023 51 51
2024 15 15

Device Problems MDRs with this Device Problem Events in those MDRs
Device Fell 54 54
Device Handling Problem 50 50
Detachment of Device or Device Component 33 33
Device Operational Issue 16 16
Poor Quality Image 15 15
Break 7 7
Output Problem 4 4
Failure to Align 3 3
No Display/Image 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Unintended Movement 3 3
Misassembly During Maintenance/Repair 3 3
Radiation Output Problem 2 2
Misassembled During Installation 2 2
Fire 2 2
Unintended System Motion 2 2
Use of Device Problem 2 2
Improper or Incorrect Procedure or Method 2 2
Fitting Problem 2 2
Radiation Overexposure 2 2
Radiation Underexposure 1 1
Therapeutic or Diagnostic Output Failure 1 1
Device Dislodged or Dislocated 1 1
Material Integrity Problem 1 1
Material Twisted/Bent 1 1
Mechanical Jam 1 1
Defective Component 1 1
Failure to Advance 1 1
Device Displays Incorrect Message 1 1
Patient-Device Incompatibility 1 1
Battery Problem 1 1
Charging Problem 1 1
Failure to Power Up 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
Smoking 1 1
Image Display Error/Artifact 1 1
Loose or Intermittent Connection 1 1
Mechanical Problem 1 1
Display or Visual Feedback Problem 1 1
Component Falling 1 1
Computer Software Problem 1 1
Sharp Edges 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 91 91
Radiation Exposure, Unintended 17 17
No Known Impact Or Consequence To Patient 14 14
No Consequences Or Impact To Patient 11 11
No Patient Involvement 9 9
Bone Fracture(s) 4 4
Injury 3 3
Laceration(s) 3 3
Damage to Ligament(s) 2 2
Skin Tears 2 2
Shock 1 1
Concussion 1 1
Abrasion 1 1
Bruise/Contusion 1 1
Eye Injury 1 1
Fall 1 1
Hip Fracture 1 1
Hair Loss 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 LIEBEL-FLARSHEIM COMPANY LLC II Jul-02-2021
7 Palodex Group Oy II Jan-24-2020
8 Philips Healthcare II Nov-24-2021
9 Philips North America Llc II Jun-30-2023
10 Siemens Medical Solutions USA, Inc II May-05-2020
11 Swissray Medical AG II Jan-08-2019
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