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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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New Search show TPLC since Back to Search Results
Device device, automated cell-locating
Product CodeJOY
Regulation Number 864.5260
Device Class 2


Premarket Reviews
ManufacturerDecision
CELLAVISION AB
  SUBSTANTIALLY EQUIVALENT 1
SCOPIO LABS LTD.
  SUBSTANTIALLY EQUIVALENT 2
SIGTUPLE TECHNOLOGIES PVT. LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 3 3
2022 2 2
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Use of Device Problem 5 5
Adverse Event Without Identified Device or Use Problem 2 2
Program or Algorithm Execution Problem 1 1
Patient Data Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5 5
No Consequences Or Impact To Patient 2 2
No Patient Involvement 1 1

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