K220539 is an FDA 510(k) clearance for the Klarity SRS Baseplate, Klarity Promise Baseplate. This device is classified as a Accelerator, Linear, Medical (Class II - Special Controls, product code IYE).
Submitted by Klarity Medical & Equipment (GZ) Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on November 1, 2022, 249 days after receiving the submission on February 25, 2022.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5050.
| 510(k) Number | K220539 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 25, 2022 |
| Decision Date | November 01, 2022 |
| Days to Decision | 249 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Statement |
| Product Code | IYE - Accelerator, Linear, Medical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.5050 |