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TPLC
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Device
device, automated cell-locating
Product Code
JOY
Regulation Number
864.5260
Device Class
2
Premarket Reviews
Manufacturer
Decision
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
4
4
Device Problems
MDRs with this Device Problem
Events in those MDRs
Use of Device Problem
6
6
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
6
6
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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