DEN230020 is an FDA 510(k) submission for the BioTraceIO Lite. This device is classified as a Post-ablation Tissue Response Prediction Software (Class II - Special Controls, product code QZL).
Submitted by Techsomed Medical Technologies , Ltd. (Rehovot, IL). The FDA issued a Not Cleared (DENG) decision on December 22, 2023.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2052. A Post-ablation Tissue Response Prediction Software Is An Image Processing Device Intended To Aid Physicians With Adjunctive Information In Their Clinical Assessment Of The Ablation Zone Following A Tissue Ablation Procedure. This Device Uses Information Extracted From Medical Images Along With Other Clinical Data To Predict The Ablation Zone Post Treatment..
| 510(k) Number | DEN230020 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | March 30, 2023 |
| Decision Date | December 22, 2023 |
| Days to Decision | 267 days |
| Submission Type | Direct |
| Review Panel | Radiology (RA) |
| Summary | - |
| Product Code | QZL - Post-ablation Tissue Response Prediction Software |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.2052 |
| Definition | A Post-ablation Tissue Response Prediction Software Is An Image Processing Device Intended To Aid Physicians With Adjunctive Information In Their Clinical Assessment Of The Ablation Zone Following A Tissue Ablation Procedure. This Device Uses Information Extracted From Medical Images Along With Other Clinical Data To Predict The Ablation Zone Post Treatment. |