AudaxCeph Cephalogram Analysis Software— 510(k) K243005

Substantially Equivalent

Audax D.O.O.

FDA 510(k) clearance K243005 for AudaxCeph Cephalogram Analysis Software, Substantially Equivalent on 2025-05-30. Applicant: Audax D.O.O..

Clearance details

Applicant: Audax D.O.O.
Product code: Code QIH
Advisory panel: Radiology
Date received: 2024-09-26
Decision date: 2025-05-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ljubljana, SI

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