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U.S. Department of Health and Human Services

Product Classification

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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 .
Physical State The device is software only.
Technical Method The device provides triage or notification that is informed by machine learning, artificial intelligence or other image analysis algorithms.
Target Area The device operates on radiological images of the human body.
Regulation Medical Specialty Radiology
Review Panel Radiology
Product CodeQAS
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 892.2080
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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