K240796 is an FDA 510(k) clearance for the myAblation Guide (VB80A). 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 Siemens Healthcare GmbH (Erlanger, DE). The FDA issued a Cleared decision on August 6, 2024, 137 days after receiving the submission on March 22, 2024.
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 | K240796 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 22, 2024 |
| Decision Date | August 06, 2024 |
| Days to Decision | 137 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. |