• 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 camera, scintillation (gamma)
Product CodeIYX
Regulation Number 892.1100
Device Class 1


Premarket Reviews
ManufacturerDecision
RADIOPHARMACEUTICAL IMAGING AND DOSIMETRY, LLC
  SUBSTANTIALLY EQUIVALENT 1
VERSANT MEDICAL PHYSICS AND RADIATION SAFETY
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 1 1
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Device Fell 1 1
Loss of Data 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Information 1 1
Bone Fracture(s) 1 1

-
-