DEN230020
- 510(k) number
- DEN230020
- Device name
- BioTraceIO Lite
- Applicant
- Techsomed Medical Technologies , Ltd. IL
- Product code
- QZL — Post-Ablation Tissue Response Prediction Software
- Decision date
- 2023-12-22
- Date received
- 2023-03-30
- Decision
- Unknown
- Clearance type
- Direct
- Advisory committee
- Radiology
Official FDA record: DEN230020
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.