Annalise Enterprise CXR Triage Trauma— 510(k) K222179

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..

Clearance details

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

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