Annalise Enterprise CTB Triage-OH— 510(k) K231094

Name: FDA 510(k) clearance K231094
Creator: U.S. Food and Drug Administration
Published: 2023-08-15

Substantially Equivalent

Annalise-Ai Pty , Ltd.

FDA 510(k) clearance K231094 for Annalise Enterprise CTB Triage-OH, Substantially Equivalent on 2023-08-15. 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: 2023-04-18
Decision date: 2023-08-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sydney, AU

Download summary PDF View on FDA.gov ↗

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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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K231384 — Annalise Enterprise CTB Triage Trauma2023-09-22
K231767 — Annalise Enterprise CTB Triage Trauma2023-09-22
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.