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TPLC - Total Product Life Cycle
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Device pathology software algorithm device analyzing digital images for cancer prognosis
Definition A pathology software algorithm device analyzing digital images for cancer prognosis is a software intended to analyze scanned whole slide images (WSIs) from prostate biopsies prepared from formalin fixed paraffin-embedded (FFPE) tissue and stained using Hematoxylin & Eosin (H&E) stains. The device provides prognostic risk estimates which are intended to assist physicians with prognostic risk-based decisions along with other clinicopathological factors. The device is not intended to determine a clinical diagnosis.
Product CodeSFH
Regulation Number 864.3755
Device Class 2


Premarket Reviews
ManufacturerDecision
ARTERA, INC.
  GRANTED 1

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