K140528 is an FDA 510(k) clearance for the TRUE BEAM, TRUE BEAM STX, EDGE. This device is classified as a Accelerator, Linear, Medical (Class II - Special Controls, product code IYE).
Submitted by Varian Medical Systems, Inc. (Palo Alto, US). The FDA issued a Cleared decision on September 5, 2014, 185 days after receiving the submission on March 4, 2014.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5050.
| 510(k) Number | K140528 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 04, 2014 |
| Decision Date | September 05, 2014 |
| Days to Decision | 185 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 |