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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 6
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 52 52

Device Problems MDRs with this Device Problem Events in those MDRs
Device Fell 86 86
Device Handling Problem 79 79
Detachment of Device or Device Component 36 36
Device Operational Issue 16 16
Poor Quality Image 15 15
Break 7 7
Output Problem 4 4
Use of Device Problem 4 4
No Display/Image 3 3
Unintended Movement 3 3
Failure to Align 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Misassembly During Maintenance/Repair 3 3
Fitting Problem 2 2
Radiation Output Problem 2 2
Fire 2 2
Improper or Incorrect Procedure or Method 2 2
Unintended System Motion 2 2
Radiation Overexposure 2 2
Misassembled During Installation 2 2
Component Falling 1 1
Mechanical Jam 1 1
Device Displays Incorrect Message 1 1
Loose or Intermittent Connection 1 1
Display or Visual Feedback Problem 1 1
Self-Activation or Keying 1 1
Device Dislodged or Dislocated 1 1
Failure to Advance 1 1
Computer Software Problem 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Retraction Problem 1 1
Use of Incorrect Control/Treatment Settings 1 1
Sharp Edges 1 1
Charging Problem 1 1
Material Twisted/Bent 1 1
Failure to Power Up 1 1
Battery Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Material Integrity Problem 1 1
Defective Component 1 1
Smoking 1 1
Patient-Device Incompatibility 1 1
Image Display Error/Artifact 1 1
Mechanical Problem 1 1
Radiation Underexposure 1 1
Device Slipped 1 1
Failure to Read Input Signal 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 127 127
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
Insufficient Information 2 2
Skin Tears 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Hip Fracture 1 1
Abrasion 1 1
Concussion 1 1
Unspecified Eye / Vision Problem 1 1
Fall 1 1
Hair Loss 1 1
Eye Injury 1 1
Shock 1 1
Bruise/Contusion 1 1
Unintended Radiation Exposure 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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