K243084 is an FDA 510(k) clearance for the BioTraceIO Precision (2.0). 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 Cleared decision on December 27, 2024, 88 days after receiving the submission on September 30, 2024.
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 | K243084 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 30, 2024 |
| Decision Date | December 27, 2024 |
| Days to Decision | 88 days |
| Submission Type | Special |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| 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. |