AudaxCeph Cephalogram Analysis Software— 510(k) K243005

Name: FDA 510(k) clearance K243005
Creator: U.S. Food and Drug Administration
Published: 2025-05-30

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.. Device class: 2.

Clearance details

Applicant: Audax D.O.O.
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2024-09-26
Decision date: 2025-05-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ljubljana, SI

Download summary PDF View on FDA.gov ↗

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