BriefCase-Quantification— 510(k) K230534

Substantially Equivalent

Aidoc Medical , Ltd.

FDA 510(k) clearance K230534 for BriefCase-Quantification, Substantially Equivalent on 2023-11-08. Applicant: Aidoc Medical , Ltd.. Device class: 2.

Clearance details

Applicant: Aidoc Medical , Ltd.
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2023-02-27
Decision date: 2023-11-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tell-Aviv, IL

Download summary PDF View on FDA.gov ↗

Recent devices under product code QIH

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K261795 — Quicktome Software Suite2026-09-10
K251417 — ReVISION 22026-09-09
K260525 — NextMR Spine2026-09-04
K260811 — Heartvue.Proton2026-08-26

More clearances from Aidoc Medical , Ltd.

K261317 — BriefCase-Triage2026-05-14
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

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