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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 a medical device manufactured by Audax D.O.O.. It received FDA 510(k) clearance on 2025-05-30 under approval 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. It is manufactured by Audax D.O.O.. The 510(k) number is K243005.

When was AudaxCeph Cephalogram Analysis Software approved by the FDA?

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

What company makes AudaxCeph Cephalogram Analysis Software?

AudaxCeph Cephalogram Analysis Software is manufactured by Audax D.O.O..

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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Related PubMed Literature

PMID: 41476571 Digital pathology imaging artificial intelligence in cancer research and clinical trials: An NCI workshop report. Journal of pathology informatics (2026) PMID: 40400654 Prescription Digital Therapeutics Research Across Clinical, Engagement, Regulatory, and Implementation Domains: A Bibliometric and Thematic Study. Cureus (2025) PMID: 40395709 Decoding FDA Labeling of Prescription Digital Therapeutics: A Cross-Sectional Regulatory Study. Cureus (2025) PMID: 37966871 Collection and Analysis of Adherence Information for Software as a Medical Device Clinical Trials: Systematic Review. JMIR mHealth and uHealth (2023)

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Official Source

View on FDA Database →

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