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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device microscope, automated, image analysis, immunohistochemistry,operator intervention,nuclear intensity & percent positivity
Definition Automated microscopic immunohistochemistry image- analysis system to measure nuclear intensity and percent positivity with operator intervention.
Product CodeNQN
Regulation Number 864.1860
Device Class 2


Premarket Reviews
ManufacturerDecision
APPLIED SPECTRAL IMAGING LTD.
  SUBSTANTIALLY EQUIVALENT 1
BIOIMAGENE, INC.
  SUBSTANTIALLY EQUIVALENT 1
VENTANA MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 6

MDR Year MDR Reports MDR Events
2016 1 1
2017 1 1
2020 1 1
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Application Program Problem 1 1
Computer Software Problem 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Fluid/Blood Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Fall 1 1
Misdiagnosis 1 1
No Consequences Or Impact To Patient 1 1
No Known Impact Or Consequence To Patient 1 1
No Clinical Signs, Symptoms or Conditions 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Leica Biosystems Richmond Inc. III Jun-10-2016
2 Leica Microsystems, Inc. II Mar-24-2009
3 Roche Molecular Systems, Inc. II Jan-17-2021
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