K251931 is an FDA 510(k) clearance for the BioTraceIO Vision (V1.7). This device is classified as a Radiological Image Processing Software For Ablation Therapy Planning And Evaluation (Class II - Special Controls, product code QTZ).
Submitted by Techsomed Medical Technologies (Or Yehuda, IL). The FDA issued a Cleared decision on September 8, 2025, 76 days after receiving the submission on June 24, 2025.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2050. To Provide Radiological Image Processing Tools For Planning, Monitoring, And Evaluating Ablation Therapy..
| 510(k) Number | K251931 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 24, 2025 |
| Decision Date | September 08, 2025 |
| Days to Decision | 76 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | QTZ - Radiological Image Processing Software For Ablation Therapy Planning And Evaluation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.2050 |
| Definition | To Provide Radiological Image Processing Tools For Planning, Monitoring, And Evaluating Ablation Therapy. |