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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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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
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Device Fell 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Bone Fracture(s) 1 1

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