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Device radiological computer-assisted prioritization software for lesions
Definition Radiological computer-assisted prioritization software for lesions is an image processing device intended to aid in prioritization and triage of time sensitive patient detection and diagnosis based on the analysis of medical images acquired from radiological signal acquisition systems. The device identifies or prioritizes time sensitive imaging for review by prespecified clinical users based on software-based image analysis but does not provide information from the image analysis other than triage and notification.
Product CodeQFM
Regulation Number 892.2080
Device Class 2


Premarket Reviews
ManufacturerDecision
AIDOC MEDICAL, LTD.
  SUBSTANTIALLY EQUIVALENT 4
ANNALISE-AI
  SUBSTANTIALLY EQUIVALENT 1
ANNALISE-AI PTY LTD
  SUBSTANTIALLY EQUIVALENT 2
BEHOLD.AI TECHNOLOGIES LIMITED
  SUBSTANTIALLY EQUIVALENT 1
BERING LTD
  SUBSTANTIALLY EQUIVALENT 1
CUREMETRIX, INC
  SUBSTANTIALLY EQUIVALENT 1
DEEPHEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 1
ENVISIONIT DEEPAI LTD
  SUBSTANTIALLY EQUIVALENT 1
EVER FORTUNE AI CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
EVER FORTUNE.AI CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GE MEDICAL SYSTEMS, LLC.
  SUBSTANTIALLY EQUIVALENT 1
ISCHEMAVIEW INC.
  SUBSTANTIALLY EQUIVALENT 1
LUNIT INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDCOGNETICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
QUANTA COMPUTER INC.
  SUBSTANTIALLY EQUIVALENT 1
QURE.AI TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
RADLOGICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
RIVERAIN TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI UNITED IMAGING INTELLIGENCE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
VINBRAIN JOINT STOCK COMPANY
  SUBSTANTIALLY EQUIVALENT 1
VIZ. AI, INC.
  SUBSTANTIALLY EQUIVALENT 1
VIZ.AI, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZEBRA MEDICAL VISION LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZEBRA MEDICAL VISION LTD.
  SUBSTANTIALLY EQUIVALENT 3
ZEBRA MEDICAL VISION, LTD.
  SUBSTANTIALLY EQUIVALENT 1

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