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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device automated digital image manual interpretation microscope
Definition The ihc her2 manual read of a digital slide application is intended for use as an aid to the pathologist in the detection and semi-quantitative measurement of her2/neu (c-erbb-2) in formalin-fixed, paraffin-embedded normal and neoplastic tissue immunohistochemically stained for her-2 receptors, using microscopy images displayed on a computer monitor. Her-2 results are indicated for use as an aid in the management, prognosis and prediction of therapy outcomes in breast cancer.
Product CodeOEO
Regulation Number 864.1860
Device Class 2


Premarket Reviews
ManufacturerDecision
OLYMPUS AMERICA INC. / SCIENTIFIC EQUIPMENT GROUP
  SUBSTANTIALLY EQUIVALENT 1
OMNYX, LLC
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
  SUBSTANTIALLY EQUIVALENT 1
VENTANA MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1

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