The following data is part of a premarket notification filed by Accuray Incorporated with the FDA for Onrad Treatment System.
| Device ID | K152488 |
| 510k Number | K152488 |
| Device Name: | Onrad Treatment System |
| Classification | System, Planning, Radiation Therapy Treatment |
| Applicant | ACCURAY INCORPORATED 1209 DEMING WAY Madison, WI 53717 |
| Contact | Erin Daly |
| Correspondent | Erin Daly ACCURAY INCORPORATED 1209 DEMING WAY Madison, WI 53717 |
| Product Code | MUJ |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-31 |
| Decision Date | 2015-09-28 |
| Summary: | summary |