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TPLC - Total Product Life Cycle
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Device radiological computer assisted detection/diagnosis software for lesions suspicious for cancer
Definition A radiological computer assisted detection and diagnostic software for suspected lesions is an image processing device intended to aid in the detection, localization, and characterization of lesions suspicious for cancer on acquired medical images (e.g., mammography , MR, CT, ultrasound, radiography). The device detects, identifies and characterizes lesions suspicious for cancer based on features or information extracted from the images, and may provide information about the presence, location, and characteristics of the lesion to the user. Primary diagnostic and patient management decisions are made by the clinical user.
Product CodeQDQ
Regulation Number 892.2090
Device Class 2


Premarket Reviews
ManufacturerDecision
DEEPHEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 1
HOLOGIC, INC.
  SUBSTANTIALLY EQUIVALENT 3
ICAD INC.
  SUBSTANTIALLY EQUIVALENT 2
LUNIT INC.
  SUBSTANTIALLY EQUIVALENT 2
SCANMED, LLC
  SUBSTANTIALLY EQUIVALENT 1
SCREENPOINT MEDICAL B.V.
  SUBSTANTIALLY EQUIVALENT 4
TAIHAO MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
THERAPIXEL
  SUBSTANTIALLY EQUIVALENT 2

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