Annalise Enterprise CTB Triage Trauma— 510(k) K231384

Name: FDA 510(k) clearance K231384
Creator: U.S. Food and Drug Administration
Published: 2023-09-22

Substantially Equivalent

Annalise-Ai Pty , Ltd.

FDA 510(k) clearance K231384 for Annalise Enterprise CTB Triage Trauma, Substantially Equivalent on 2023-09-22. Applicant: Annalise-Ai Pty , Ltd.. Device class: 2.

Clearance details

Applicant: Annalise-Ai Pty , Ltd.
Product code: Code QAS
Device class: Class 2
Regulation: 21 CFR 892.2080
Advisory panel: Radiology
Date received: 2023-05-12
Decision date: 2023-09-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sydney, AU

Download summary PDF View on FDA.gov ↗

Recent devices under product code QAS

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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 Annalise-Ai Pty , Ltd.

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K231767 — Annalise Enterprise CTB Triage Trauma2023-09-22
K231094 — Annalise Enterprise CTB Triage-OH2023-08-15
K223240 — Annalise Enterprise CTB Triage Trauma2023-04-03
K222179 — Annalise Enterprise CXR Triage Trauma2023-03-28
K222268 — Annalise Enterprise CXR Triage Trauma2023-03-28

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