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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device device, automated cell-locating
Regulation Description Automated cell-locating device.
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
2022 2 2
2024 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Use of Device Problem 6 6
Insufficient Information 1 1
Program or Algorithm Execution Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7 7

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