510(k) K253818

Clearance Details

Decision

SESE (Substantially Equivalent)

Decision Date

March 3, 2026

Date Received

November 28, 2025

Clearance Type

Traditional

Expedited Review

No

Third Party Review

No

Device Classification

Device Name

Radiological Computer-Assisted Triage And Notification Software

Device Class

Class II

Regulation Number

892.2080

Review Panel

RA

Submission Type

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 .