BriefCase-Triage— 510(k) K251406

Substantially Equivalent

Aidoc Medical , Ltd.

FDA 510(k) clearance K251406 for BriefCase-Triage, Substantially Equivalent on 2025-05-30. Applicant: Aidoc Medical , Ltd.. Device class: 2.

Clearance details

Applicant: Aidoc Medical , Ltd.
Product code: Code QAS
Device class: Class 2
Regulation: 21 CFR 892.2080
Advisory panel: Radiology
Date received: 2025-05-06
Decision date: 2025-05-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Tell-Aviv, IL

Download summary PDF View on FDA.gov ↗

Recent devices under product code QAS

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K260729 — Vascular Assist Occlusion Triage (VAOT) (v1.0)2026-06-18
K261317 — BriefCase-Triage2026-05-14
K253163 — EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100)2026-04-22
K252421 — JLK-NCCT2026-03-24

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
K250248 — BriefCase-Triage2025-02-14

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