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FDA-cleared K252665

brAIn™ Shoulder Positioning

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Authorized purpose: brAIn Shoulder Positioning assists preoperative planning and visualization for primary total shoulder replacement by segmenting and measuring shoulder CT anatomy and supporting manual implant planning.

Modality
CT/CTA
Anatomy
Shoulder, scapula, and humerus
Decision
2025-10-20
FDA-cleared K243292

brAIn™ Shoulder Positioning

Avatar Medical

Authorized purpose: brAIn Shoulder Positioning assists shoulder surgeons with preoperative planning and visualization for primary total shoulder replacement by segmenting shoulder CT data and allowing interactive implant positioning; it is an information tool and does not make the final surgical decision.

Modality
CT/CTA
Anatomy
Shoulder/scapula/humerus
Decision
2025-03-20