The following data is part of a premarket notification filed by Accuray Incorporated with the FDA for Cyberknife Robotic Radiosurgery System Cyberknife Vsi Robotic Radiosurgery System.
Device ID | K122137 |
510k Number | K122137 |
Device Name: | CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM CYBERKNIFE VSI ROBOTIC RADIOSURGERY SYSTEM |
Classification | Accelerator, Linear, Medical |
Applicant | ACCURAY INCORPORATED 1310 CHESAPEAKE TERRACE Sunnyvale, CA 94089 |
Contact | Anne Schlagenhaft |
Correspondent | Anne Schlagenhaft 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 | 2012-07-18 |
Decision Date | 2012-10-26 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00811376030498 | K122137 | 000 |
00811376030467 | K122137 | 000 |
00811376030450 | K122137 | 000 |
00811376030443 | K122137 | 000 |
00811376030436 | K122137 | 000 |
00811376030429 | K122137 | 000 |