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FDA-cleared K243810

TraumaCad Neo (1.1)

Brainlab Ltd.

Authorized purpose: TraumaCad Neo assists healthcare professionals in analyzing orthopedic conditions and planning orthopedic procedures by overlaying measurements and prosthesis templates on relevant radiological images; it is not primary radiological interpretation and clinical judgment remains required.

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Hip, knee, upper-limb, and foot orthopedic anatomy represented in X-ray or CT studies
Decision
2025-06-04