K252665

brAIn™ Shoulder Positioning

510(k) number
K252665
Device name
brAIn™ Shoulder Positioning
Applicant
Avatar Medical FR
Product code
QIH — Automated Radiological Image Processing Software
Decision date
2025-10-20
Date received
2025-08-25
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Radiology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain

Also available from FDA: K252665.pdf

Official FDA record: K252665
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.