Annalise Enterprise CXR Triage Trauma— 510(k) K222179

Name: FDA 510(k) clearance K222179
Creator: U.S. Food and Drug Administration
Published: 2023-03-28

Substantially Equivalent

Annalise-Ai Pty , Ltd.

FDA 510(k) clearance K222179 for Annalise Enterprise CXR Triage Trauma, Substantially Equivalent on 2023-03-28. Applicant: Annalise-Ai Pty , Ltd.. Device class: 2.

Clearance details

Applicant: Annalise-Ai Pty , Ltd.
Product code: Code QFM
Device class: Class 2
Regulation: 21 CFR 892.2080
Advisory panel: Radiology
Date received: 2022-07-22
Decision date: 2023-03-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sydney, AU

Download summary PDF View on FDA.gov ↗

Recent devices under product code QFM

view all

More clearances from Annalise-Ai Pty , Ltd.

view all

K231384 — Annalise Enterprise CTB Triage Trauma2023-09-22
K231767 — Annalise Enterprise CTB Triage Trauma2023-09-22
K231094 — Annalise Enterprise CTB Triage-OH2023-08-15
K223240 — Annalise Enterprise CTB Triage Trauma2023-04-03
K222268 — Annalise Enterprise CXR Triage Trauma2023-03-28

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