BriefCase— 510(k) K190072

Substantially Equivalent

Aidoc Medical , Ltd.

FDA 510(k) clearance K190072 for BriefCase, Substantially Equivalent on 2019-04-15. 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: 2019-01-15
Decision date: 2019-04-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tel Aviv, IL

Download summary PDF View on FDA.gov ↗

Recent devices under product code QAS

K261085 — Rapid Vessel Occlusion (Rapid VO)2026-07-13
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
K251406 — BriefCase-Triage2025-05-30

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