K231573 is an FDA 510(k) clearance for the ThinkQA (Edition 2). This device is classified as a Accelerator, Linear, Medical (Class II - Special Controls, product code IYE).
Submitted by Dosisoft SA (Cachan, FR). The FDA issued a Cleared decision on January 18, 2024, 232 days after receiving the submission on May 31, 2023.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5050.
| 510(k) Number | K231573 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 31, 2023 |
| Decision Date | January 18, 2024 |
| Days to Decision | 232 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IYE - Accelerator, Linear, Medical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.5050 |