Annalise Enterprise— 510(k) K253818

Substantially Equivalent

Harrison-AI Medical Pty, Ltd.

FDA 510(k) clearance K253818 for Annalise Enterprise, Substantially Equivalent on 2026-03-03. Applicant: Harrison-AI Medical Pty, Ltd..

Clearance details

Applicant: Harrison-AI Medical Pty, Ltd.
Product code: Code QAS
Advisory panel: Radiology
Date received: 2025-11-28
Decision date: 2026-03-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sydney, AU

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