BriefCase-Triage— 510(k) K261317

Substantially Equivalent

Aidoc Medical , Ltd.

FDA 510(k) clearance K261317 for BriefCase-Triage, Substantially Equivalent on 2026-05-14. Applicant: Aidoc Medical , Ltd.. Device class: 2.

Summary

Aidoc Medical's BriefCase-Triage is filed under QAS, radiological computer-assisted triage and notification software.

Class II, 21 CFR 892.2080. Radiology is both the classification panel and the review panel. It was a Special 510(k).

Aidoc filed from Tel Aviv, Israel. Review took 23 calendar days (April 21 to May 14, 2026).

Clearance details

Applicant: Aidoc Medical , Ltd.
Product code: Product code QAS
Device class: Class 2
Regulation: 21 CFR 892.2080
Advisory panel: Radiology
Date received: 2026-04-21
Decision date: 2026-05-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Tel Aviv, IL

Download summary PDF View on FDA.gov ↗

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More clearances from Aidoc Medical , Ltd.

K253578 — BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax +3 more2026-02-26
K251195 — BriefCase-Triage2026-01-27
K252970 — BriefCase-Triage: CARE Multi-triage CT Body2026-01-07
K253265 — BriefCase-Triage2025-11-06
K251406 — BriefCase-Triage2025-05-30

Data sourced from openFDA. This site is unofficial and independent of the FDA.