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FDA 510(k)

CEPHX- Cephalometric Analysis Software

K-Number: K231396 · 2024-01-31

ApplicantOrca Dental AI , Ltd.
Decision Date2024-01-31
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CEPHX- Cephalometric Analysis Software is a medical device manufactured by Orca Dental AI , Ltd.. It received FDA 510(k) clearance on 2024-01-31 under approval number K231396. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CEPHX- Cephalometric Analysis Software?

CEPHX- Cephalometric Analysis Software is a medical device that received FDA 510(k) clearance on 2024-01-31. It is manufactured by Orca Dental AI , Ltd.. The 510(k) number is K231396.

When was CEPHX- Cephalometric Analysis Software approved by the FDA?

CEPHX- Cephalometric Analysis Software received FDA 510(k) clearance on 2024-01-31, under approval number K231396.

What company makes CEPHX- Cephalometric Analysis Software?

CEPHX- Cephalometric Analysis Software is manufactured by Orca Dental AI , Ltd..

What is the FDA product code for CEPHX- Cephalometric Analysis Software?

The FDA product code for CEPHX- Cephalometric Analysis Software is LLZ.

Related Clinical Trials

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Related PubMed Literature

PMID: 41938602 AI-enabled cardiovascular devices: a lifecycle playbook for evidence, change control, and post-market assurance. Frontiers in digital health (2026) PMID: 41714355 The AI Act and the MDR post-market requirements for semiautonomous AI SaMD: a radiology case study in prostate cancer. Abdominal radiology (New York) (2026) PMID: 41543479 Ethical and Regulatory Considerations for Artificial Intelligence Adoption in Craniofacial Surgery. The Journal of craniofacial surgery () PMID: 41533310 Scoping review of regulatory transparency in AI-based radiology software: analysis of PMDA-approved SaMD products. Japanese journal of radiology (2026)

Other Devices by Orca Dental AI , Ltd.

K252538CEPHX3D

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Official Source

View on FDA Database →

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