brAIn Shoulder Positioning— 510(k) K252665

Substantially Equivalent

Avatar Medical

FDA 510(k) clearance K252665 for brAIn Shoulder Positioning, Substantially Equivalent on 2025-10-20. Applicant: Avatar Medical. Device class: 2.

Clearance details

Applicant: Avatar Medical
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2025-08-25
Decision date: 2025-10-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Paris, FR

Download summary PDF View on FDA.gov ↗

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More clearances from Avatar Medical

K253950 — Avatar Medical Vision2026-03-30
K243292 — brAIn Shoulder Positioning2025-03-20
K222035 — Avatar Medical Software V12023-05-24

Data sourced from openFDA. This site is unofficial and independent of the FDA.