K243084
- 510(k) number
- K243084
- Device name
- BioTraceIO Precision (2.0)
- Applicant
- Techsomed Medical Technologies , Ltd. IL
- Product code
- QZL — Post-Ablation Tissue Response Prediction Software
- Decision date
- 2024-12-27
- Date received
- 2024-09-30
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K243084.pdf
Official FDA record: K243084
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.