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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device radiological computer-assisted triage and notification software
Regulation Description Radiological computer aided triage and notification software.
Definition Radiological computer-assisted triage and notification software 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 CodeQAS
Regulation Number 892.2080
Device Class 2


Premarket Reviews
ManufacturerDecision
AIDOC MEDICAL, LTD.
  SUBSTANTIALLY EQUIVALENT 15
ANNALISE-AI PTY LTD
  SUBSTANTIALLY EQUIVALENT 3
ANNALISE-AI PTY LTD.
  SUBSTANTIALLY EQUIVALENT 1
AVICENNA.AI
  SUBSTANTIALLY EQUIVALENT 5
BRAINOMIX LIMITED
  SUBSTANTIALLY EQUIVALENT 3
CIRCLE NEUROVASCULAR IMAGING, INC
  SUBSTANTIALLY EQUIVALENT 1
CURACLOUD CORP.
  SUBSTANTIALLY EQUIVALENT 1
EVER FORTUNE.AI CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
EVER FORTUNE.AI, CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
HEURON CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
INFERVISION MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ISCHEMAVIEW INC.
  SUBSTANTIALLY EQUIVALENT 4
ISCHEMAVIEW INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
ISCHEMAVIEW, INC.
  SUBSTANTIALLY EQUIVALENT 2
JLK, INC.
  SUBSTANTIALLY EQUIVALENT 3
MAXQ AL LTD.
  SUBSTANTIALLY EQUIVALENT 1
NEUROCAREAI INC.
  SUBSTANTIALLY EQUIVALENT 1
NICO-LAB B.V.
  SUBSTANTIALLY EQUIVALENT 1
NICO.LAB B.V.
  SUBSTANTIALLY EQUIVALENT 1
NINES, INC.
  SUBSTANTIALLY EQUIVALENT 1
QURE.AI TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI UNITED IMAGING INTELLIGENCE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS MEDICAL SOLUTIONS USA, INC.
  SUBSTANTIALLY EQUIVALENT 3
SK INC.
  SUBSTANTIALLY EQUIVALENT 1
VIZ.AI, INC.
  SUBSTANTIALLY EQUIVALENT 4

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