Annalise Enterprise— 510(k) K250831

Substantially Equivalent

Annalise-Ai

FDA 510(k) clearance K250831 for Annalise Enterprise, Substantially Equivalent on 2025-04-23. Applicant: Annalise-Ai.

Clearance details

Applicant: Annalise-Ai
Product code: Code QFM
Advisory panel: Radiology
Date received: 2025-03-19
Decision date: 2025-04-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Sydney, AU

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