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FDA 510(k)

AudaxCeph Cephalogram Analysis Software

K-Number: K243005 · 2025-05-30

ApplicantAudax D.O.O.
Decision Date2025-05-30
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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