K182687 is an FDA 510(k) clearance for the Motion Tracking and Compensation Feature for the Radixact Treatment Delivery System. This device is classified as a Accelerator, Linear, Medical (Class II - Special Controls, product code IYE).
Submitted by Accuray Incorporated (Madison, US). The FDA issued a Cleared decision on November 23, 2018, 58 days after receiving the submission on September 26, 2018.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5050.
| 510(k) Number | K182687 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 26, 2018 |
| Decision Date | November 23, 2018 |
| Days to Decision | 58 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 |