K222938 is an FDA 510(k) clearance for the Ablation-fit. 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 R.A.W. S.R.L (Milan, IT). The FDA issued a Cleared decision on September 12, 2023, 351 days after receiving the submission on September 26, 2022.
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 | K222938 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 26, 2022 |
| Decision Date | September 12, 2023 |
| Days to Decision | 351 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. |