The following data is part of a premarket notification filed by Accuray Incorporated with the FDA for Precision Treatment Planning System.
| Device ID | K161136 |
| 510k Number | K161136 |
| Device Name: | Precision Treatment Planning System |
| Classification | System, Planning, Radiation Therapy Treatment |
| Applicant | ACCURAY INCORPORATED 1310 CHESAPEAKE TERRACE Sunnyvale, CA 94089 |
| Contact | Shweta Kaushik |
| Correspondent | Shweta Kaushik ACCURAY INCORPORATED 1310 CHESAPEAKE TERRACE Sunnyvale, CA 94089 |
| Product Code | MUJ |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-22 |
| Decision Date | 2016-06-24 |
| Summary: | summary |