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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 N.V.
  SUBSTANTIALLY EQUIVALENT 2
ALLENGERS MEDICAL SYSTEMS LIMITED
  SUBSTANTIALLY EQUIVALENT 2
ASPEN IMAGING HEALTHCARE, INC.
  SUBSTANTIALLY EQUIVALENT 1
ASTEL, INC.
  SUBSTANTIALLY EQUIVALENT 1
CANON, INC.
  SUBSTANTIALLY EQUIVALENT 11
CARERAY DIGITAL MEDICAL SYSTEM CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CARERAY DIGITAL MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
CARESTREAM HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 2
DRTECH CORPORATION
  SUBSTANTIALLY EQUIVALENT 6
  1.  K223124  EXPD 86P, EXPD 86PG, EXPD 129P, EXPD 129PG
  2.  K231959  EXPD 4357; EXPD 4357P
  3.  K232082  EXPD 4343S
  4.  K232753  EXPD 4343D; EXPD 3643D
  5.  K242770  EXPD 114; EXPD 114G; EXPD 114P; EXPD 114PG
  6.  K243443  EXPD 4343N1; EXPD 4343N; EXPD 4343U1; EXPD 4343NU; ...
FIRST SOURCE, INC.
  SUBSTANTIALLY EQUIVALENT 1
H&ABYZ CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
INNOCARE OPTOELECTRONICS CORP.
  SUBSTANTIALLY EQUIVALENT 4
IRAY IMAGING TECHNOLOGY (HAINING) LIMITED
  SUBSTANTIALLY EQUIVALENT 2
IRAY TECHNOLOGY TAICANG , LTD.
  SUBSTANTIALLY EQUIVALENT 9
JPI HEALTHCARE CO, LTD.
  SUBSTANTIALLY EQUIVALENT 1
KONICA MINOLTA HEALTHCARE AMERICAS, INC.
  SUBSTANTIALLY EQUIVALENT 1
KONICA MINOLTA, INC.
  SUBSTANTIALLY EQUIVALENT 5
LG ELECTRONICS.INC
  SUBSTANTIALLY EQUIVALENT 6
MEDICATECH USA
  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 2
RAY IMAGING TECHNOLOGY (HAINING) LIMITED
  SUBSTANTIALLY EQUIVALENT 1
RAYENCE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 5
VIEWORKS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2021 26 26
2022 13 13
2023 51 51
2024 91 91
2025 142 142
2026 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Device Fell 216 216
Device Handling Problem 213 213
Detachment of Device or Device Component 61 61
Poor Quality Image 15 15
Mechanical Jam 8 8
Insufficient Information 6 6
Use of Device Problem 5 5
Fire 4 4
Sparking 3 3
Output Problem 3 3
Unintended System Motion 3 3
Smoking 3 3
Fitting Problem 2 2
Improper or Incorrect Procedure or Method 2 2
Electrical /Electronic Property Problem 2 2
Mechanical Problem 2 2
Unintended Movement 2 2
Misassembled During Installation 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Component Falling 1 1
Device Displays Incorrect Message 1 1
Display or Visual Feedback Problem 1 1
Power Problem 1 1
Device Dislodged or Dislocated 1 1
Retraction Problem 1 1
Difficult or Delayed Separation 1 1
Use of Incorrect Control/Treatment Settings 1 1
Sharp Edges 1 1
Charging Problem 1 1
Failure to Align 1 1
Material Integrity Problem 1 1
Defective Component 1 1
Difficult to Advance 1 1
Patient-Device Incompatibility 1 1
Image Display Error/Artifact 1 1
Communication or Transmission Problem 1 1
No Display/Image 1 1
Radiation Output Problem 1 1
Radiation Underexposure 1 1
Device Slipped 1 1
Circuit Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 300 300
No Patient Involvement 4 4
Unspecified Musculoskeletal problem 3 3
Bone Fracture(s) 3 3
Laceration(s) 3 3
Damage to Ligament(s) 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Insufficient Information 2 2
Muscle/Tendon Damage 2 2
Skin Tears 2 2
Hip Fracture 1 1
Joint Dislocation 1 1
Nausea 1 1
Easy Bruising 1 1
Unspecified Eye / Vision Problem 1 1
Vomiting 1 1
Hair Loss 1 1
Pain 1 1
Radiation Sickness Syndrome 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 LIEBEL-FLARSHEIM COMPANY LLC II Jul-02-2021
4 Philips Healthcare II Nov-24-2021
5 Philips Medical Systems DMC GmbH II Nov-07-2025
6 Philips North America Llc II Jun-30-2023
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