K121934 is an FDA 510(k) clearance for the TOMOTHERAPY TREATMENT 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 August 29, 2012, 58 days after receiving the submission on July 2, 2012.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5050.
| 510(k) Number | K121934 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 02, 2012 |
| Decision Date | August 29, 2012 |
| 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 |