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