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FDA-cleared K252214

AIAS Cephalon

Metamorphosis GmbH

Authorized purpose: AIAS Cephalon assists qualified healthcare professionals during adult proximal femur fracture surgery by measuring and positioning implant components relative to bone structures in intraoperative C-arm X-ray images; clinical judgment remains required and the software is not a primary image-interpretation device.

Modality
Fluoroscopy/Angiography
Anatomy
Femur/hip
Decision
2025-10-07