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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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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 EQUIPMENT FOR MEDICAL IMAGING (ONCOVISION-
  SUBSTANTIALLY EQUIVALENT 1
HERMES MEDICAL SOLUTIONS AB
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 2 2
2018 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 1 1
Loss of Data 1 1
Device Operates Differently Than Expected 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Information 2 2
No Known Impact Or Consequence To Patient 1 1

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