FDA 510(k)

Rayvolve AZchest

K-Number: K261378 · 2026-08-28

ApplicantAZmed

Decision Date2026-08-28

Product CodeQBS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Rayvolve AZchest is the device name listed in this FDA 510(k) record. The listed applicant is AZmed. It received FDA 510(k) clearance on 2026-08-28 under 510(k) number K261378. The device is classified under product code QBS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Rayvolve AZchest?

Rayvolve AZchest is a medical device that received FDA 510(k) clearance on 2026-08-28. The listed applicant is AZmed. The 510(k) number is K261378.

When did Rayvolve AZchest receive FDA 510(k) clearance?

Rayvolve AZchest received FDA 510(k) clearance on 2026-08-28, under 510(k) number K261378.

Who is the listed applicant for Rayvolve AZchest?

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

What is the FDA product code for Rayvolve AZchest?

The FDA product code for Rayvolve AZchest is QBS.

Other records listing AZmed as applicant

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.

K260378Rayvolve K243831Rayvolve LN K243808Rayvolve PTX-PE

Related Devices (Code: QBS)

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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.