FDA 510(k)

brAIn™ Shoulder Positioning

K-Number: K252665 · 2025-10-20

Decision Date2025-10-20

Product CodeQIH

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

brAIn™ Shoulder Positioning is the device name listed in this FDA 510(k) record. The listed applicant is Avatar Medical. It received FDA 510(k) clearance on 2025-10-20 under 510(k) number K252665. 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 brAIn™ Shoulder Positioning?

brAIn™ Shoulder Positioning is a medical device that received FDA 510(k) clearance on 2025-10-20. The listed applicant is Avatar Medical. The 510(k) number is K252665.

When did brAIn™ Shoulder Positioning receive FDA 510(k) clearance?

brAIn™ Shoulder Positioning received FDA 510(k) clearance on 2025-10-20, under 510(k) number K252665.

Who is the listed applicant for brAIn™ Shoulder Positioning?

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

What is the FDA product code for brAIn™ Shoulder Positioning?

The FDA product code for brAIn™ Shoulder Positioning is QIH.

Other records listing Avatar Medical 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.

K253950Avatar Medical Vision K243292brAIn™ Shoulder Positioning K222035Avatar Medical Software V1

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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.