Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device radiological computer-assisted 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 4
BRAINOMIX LIMITED
  SUBSTANTIALLY EQUIVALENT 3
CIRCLE NEUROVASCULAR IMAGING, INC
  SUBSTANTIALLY EQUIVALENT 1
CURACLOUD CORP.
  SUBSTANTIALLY EQUIVALENT 1
DEEP01 LIMITED
  SUBSTANTIALLY EQUIVALENT 1
EVER FORTUNE.AI CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
EVER FORTUNE.AI, 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
MAXQ AL LTD.
  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
SIEMENS MEDICAL SOLUTIONS USA, INC.
  SUBSTANTIALLY EQUIVALENT 2
VIZ.AI, INC.
  SUBSTANTIALLY EQUIVALENT 4
ZEBRA MEDICAL VISION LTD.
  SUBSTANTIALLY EQUIVALENT 1

-
-