K223639 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 August 28, 2023, 266 days after receiving the submission on December 5, 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 | K223639 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 05, 2022 |
| Decision Date | August 28, 2023 |
| Days to Decision | 266 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. |