FDA 510(k)

CadAI-B Dx

K-Number: K260086 · 2026-08-12

Decision Date2026-08-12

Product CodeQDQ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

CadAI-B Dx is the device name listed in this FDA 510(k) record. The listed applicant is BeamWorks, Inc.. It received FDA 510(k) clearance on 2026-08-12 under 510(k) number K260086. The device is classified under product code QDQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CadAI-B Dx?

CadAI-B Dx is a medical device that received FDA 510(k) clearance on 2026-08-12. The listed applicant is BeamWorks, Inc.. The 510(k) number is K260086.

When did CadAI-B Dx receive FDA 510(k) clearance?

CadAI-B Dx received FDA 510(k) clearance on 2026-08-12, under 510(k) number K260086.

Who is the listed applicant for CadAI-B Dx?

The FDA 510(k) record lists BeamWorks, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CadAI-B Dx?

The FDA product code for CadAI-B Dx is QDQ.

Related Devices (Code: QDQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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