FDA-cleared K251931

BioTraceIO Vision (V1.7)

Techsomed Medical Technologies

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