Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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
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 2
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 6
  1.  K210985  1717FCC
  2.  K212753  0909FCB, 1212FCA
  3.  K231467  1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF
  4.  K240371  0909FCC, 0909FCC-HS
  5.  K242394  Digital Flat Panel X-ray Detector (1717WCE, 1717WC ...
  6.  K253800  0909FCE, 0909FCE-HS
VIEWORKS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4

MDR Year MDR Reports MDR Events
2021 26 26
2022 13 13
2023 51 51
2024 91 91
2025 142 142
2026 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Device Fell 217 217
Device Handling Problem 214 214
Detachment of Device or Device Component 65 65
Poor Quality Image 14 14
Mechanical Jam 8 8
Insufficient Device Problem Information 6 6
Fire 5 5
Smoking 3 3
Use of Device Problem 3 3
Unintended System Motion 3 3
Electrical /Electronic Property Problem 3 3
Fitting Problem 2 2
Sparking 2 2
Mechanical Problem 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
Circuit Failure 1 1
Device Slipped 1 1
Radiation Underexposure 1 1
Radiation Output Problem 1 1
No Display/Image 1 1
Communication or Transmission Problem 1 1
Image Display Error/Artifact 1 1
Patient-Device Incompatibility 1 1
Difficult to Advance 1 1
Unintended Movement 1 1
Material Integrity Problem 1 1
Failure to Align 1 1
Use of Incorrect Control/Treatment Settings 1 1
Difficult or Delayed Separation 1 1
Retraction Problem 1 1
Device Dislodged or Dislocated 1 1
Power Problem 1 1
Display or Visual Feedback Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 305 305
Unspecified Musculoskeletal problem 4 4
No Patient Involvement 4 4
Bone Fracture(s) 3 3
Laceration(s) 3 3
Damage to Ligament(s) 2 2
Insufficient Information 2 2
Muscle/Tendon Damage 2 2
Skin Tears 2 2
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 2 2
Hip Fracture 1 1
Joint Dislocation 1 1
Nausea 1 1
Easy Bruising 1 1
Vomiting 1 1
Unspecified Eye / Vision Problem 1 1
Dyspnea 1 1
Hair Loss 1 1
Pain 1 1
Radiation Sickness Syndrome 1 1
Eye Injury 1 1
Joint Impingement 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-05-2026
7 Philips North America Llc II Jun-30-2023
-
-