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FDA-cleared K251931

BioTraceIO Vision (V1.7)

Techsomed Medical Technologies

Authorized purpose: BioTraceIO Vision V1.7 processes CT and MR images to support ablation target and needle planning and zone confirmation for the labeled liver and kidney workflows.

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Liver; kidney; and ablation target anatomy
Decision
2025-09-08