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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
ASPEN IMAGING HEALTHCARE INC
  SUBSTANTIALLY EQUIVALENT 1
ASTEL INC.
  SUBSTANTIALLY EQUIVALENT 1
BONTECH CO. LTD
  SUBSTANTIALLY EQUIVALENT 1
CANON INC.
  SUBSTANTIALLY EQUIVALENT 10
CANON, INC.
  SUBSTANTIALLY EQUIVALENT 1
CARERAY DIGITAL MEDICAL SYSTEM CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
CARERAY DIGITAL MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
CARESTREAM HEALTH
  SUBSTANTIALLY EQUIVALENT 1
CARESTREAM HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 3
DENTIUM CO., LTD (ICT BRANCH)
  SUBSTANTIALLY EQUIVALENT 1
DRTECH CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
FIRST SOURCE, INC.
  SUBSTANTIALLY EQUIVALENT 1
FUJIFILM CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
H&ABYZ
  SUBSTANTIALLY EQUIVALENT 1
H&ABYZ CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
INNOCARE OPTOELECTRONICS CORP.
  SUBSTANTIALLY EQUIVALENT 4
IRAY TECHNOLOGY TAICANG LTD.
  SUBSTANTIALLY EQUIVALENT 12
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 1
PIXXGEN CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
PROGNOSYS MEDICAL SYSTEMS PRIVATE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
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
VIEWORKS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4

MDR Year MDR Reports MDR Events
2020 9 9
2021 26 26
2022 13 13
2023 51 51
2024 92 92

Device Problems MDRs with this Device Problem Events in those MDRs
Device Fell 112 112
Device Handling Problem 106 106
Detachment of Device or Device Component 41 41
Poor Quality Image 16 16
Output Problem 4 4
Break 3 3
Use of Device Problem 3 3
Unintended System Motion 3 3
Fitting Problem 2 2
Radiation Output Problem 2 2
Fire 2 2
Unintended Movement 2 2
Misassembled During Installation 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Improper or Incorrect Procedure or Method 2 2
Radiation Underexposure 1 1
No Display/Image 1 1
Mechanical Problem 1 1
Communication or Transmission Problem 1 1
Image Display Error/Artifact 1 1
Patient-Device Incompatibility 1 1
Smoking 1 1
Defective Component 1 1
Material Integrity Problem 1 1
Failure to Align 1 1
Charging Problem 1 1
Sharp Edges 1 1
Use of Incorrect Control/Treatment Settings 1 1
Retraction Problem 1 1
Optical Obstruction 1 1
Display or Visual Feedback Problem 1 1
Mechanical Jam 1 1
Component Falling 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 166 166
No Patient Involvement 7 7
Laceration(s) 3 3
No Consequences Or Impact To Patient 3 3
Damage to Ligament(s) 2 2
Bone Fracture(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
Radiation Exposure, Unintended 1 1
Easy Bruising 1 1
No Known Impact Or Consequence To Patient 1 1
Unspecified Eye / Vision Problem 1 1
Hair Loss 1 1
Eye Injury 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 LIEBEL-FLARSHEIM COMPANY LLC II Jul-02-2021
5 Palodex Group Oy II Jan-24-2020
6 Philips Healthcare II Nov-24-2021
7 Philips North America Llc II Jun-30-2023
8 Siemens Medical Solutions USA, Inc II May-05-2020
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