K240773 is an FDA 510(k) clearance for the VisAble.IO. 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 (Rehovot, IL). The FDA issued a Cleared decision on April 15, 2024, 25 days after receiving the submission on March 21, 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 | K240773 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 21, 2024 |
| Decision Date | April 15, 2024 |
| Days to Decision | 25 days |
| Submission Type | Special |
| 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. |