The following data is part of a premarket notification filed by Accuray Incorportaed with the FDA for Cyberknife Treatment Delivery System.
| Device ID | K170788 |
| 510k Number | K170788 |
| Device Name: | CyberKnife Treatment Delivery System |
| Classification | Accelerator, Linear, Medical |
| Applicant | Accuray Incorportaed 1310 Chesapeake Terrace Sunnyvale, CA 94089 |
| Contact | Jyoti Singh |
| Correspondent | Jyoti Singh Accuray Incorportaed 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 | 2017-03-16 |
| Decision Date | 2017-04-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811376030023 | K170788 | 000 |
| M65806600000 | K170788 | 000 |