Annalise Enterprise CXR Triage Pneumothorax— 510(k) K213941

Name: FDA 510(k) clearance K213941
Creator: U.S. Food and Drug Administration
Published: 2022-02-24

Substantially Equivalent

Annalise-Ai

FDA 510(k) clearance K213941 for Annalise Enterprise CXR Triage Pneumothorax, Substantially Equivalent on 2022-02-24. Applicant: Annalise-Ai. Device class: 2.

Clearance details

Applicant: Annalise-Ai
Product code: Code QFM
Device class: Class 2
Regulation: 21 CFR 892.2080
Advisory panel: Radiology
Date received: 2021-12-16
Decision date: 2022-02-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sydney, AU

Download summary PDF View on FDA.gov ↗

Recent devices under product code QFM

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K253751 — CXRDetectAI2026-07-08
K252954 — MammoSightAI2026-05-04
K252482 — CogNet AI-MT+2025-12-11
K250831 — Annalise Enterprise2025-04-23
K243808 — Rayvolve PTX-PE2025-03-21

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