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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)
Regulation Description Scintillation (gamma) camera.
Product CodeIYX
Regulation Number 892.1100
Device Class 1


Premarket Reviews
ManufacturerDecision
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 1
GENERAL ELECTRIC CO.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Adverse Event Without Identified Device or Use Problem 2
Use of Device Problem 2
Device Handling Problem 1
Mechanical Problem 1
Total Device Problems 6

Recalls
Manufacturer Recall Class Date Posted
1 Siemens Medical Solutions USA, Inc. II Sep-08-2016

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