FDA 510(k)

AudaxCeph Cephalogram Analysis Software

Número K: K243005 · 2025-05-30

Data da decisão2025-05-30

Código do produtoQIH

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

AudaxCeph Cephalogram Analysis Software is the device name listed in this FDA 510(k) record. The listed applicant is Audax D.O.O.. It received FDA 510(k) clearance on 2025-05-30 under 510(k) number K243005. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the AudaxCeph Cephalogram Analysis Software?

AudaxCeph Cephalogram Analysis Software is a medical device that received FDA 510(k) clearance on 2025-05-30. The listed applicant is Audax D.O.O.. The 510(k) number is K243005.

When did AudaxCeph Cephalogram Analysis Software receive FDA 510(k) clearance?

AudaxCeph Cephalogram Analysis Software received FDA 510(k) clearance on 2025-05-30, under 510(k) number K243005.

Who is the listed applicant for AudaxCeph Cephalogram Analysis Software?

The FDA 510(k) record lists Audax D.O.O. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AudaxCeph Cephalogram Analysis Software?

The FDA product code for AudaxCeph Cephalogram Analysis Software is QIH.

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