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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
Product CodeJOY
Regulation Number 864.5260
Device Class 2


Premarket Reviews
ManufacturerDecision
CELLA VISION AB
  SUBSTANTIALLY EQUIVALENT 1
CELLAVISION AB
  SUBSTANTIALLY EQUIVALENT 3
MEDICA CORP.
  SUBSTANTIALLY EQUIVALENT 1
SCOPIO LABS LTD.
  SUBSTANTIALLY EQUIVALENT 2
SIGTUPLE TECHNOLOGIES PVT. LTD.
  SUBSTANTIALLY EQUIVALENT 1
SYSMEX AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 4 4
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
Display or Visual Feedback Problem 4 4
Patient Data Problem 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Program or Algorithm Execution Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5 5
No Known Impact Or Consequence To Patient 4 4
No Consequences Or Impact To Patient 2 2
No Patient Involvement 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cellavision AB II Jun-13-2018
2 Leica Biosystems Richmond Inc. III Jun-20-2016
3 Roche Diagnostics Hematology II Jul-26-2018
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