The following data is part of a premarket notification filed by Accuray Incorporated with the FDA for Accuray Precision Treatment Planning System.
| Device ID | K171086 |
| 510k Number | K171086 |
| Device Name: | Accuray Precision Treatment Planning System |
| Classification | Accelerator, Linear, Medical |
| 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 | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-12 |
| Decision Date | 2017-06-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811376030092 | K171086 | 000 |
| 00811376030146 | K171086 | 000 |