The following data is part of a premarket notification filed by Accuray Incorporated with the FDA for Robocouch Patient Support System.
| Device ID | K042146 |
| 510k Number | K042146 |
| Device Name: | ROBOCOUCH PATIENT SUPPORT SYSTEM |
| Classification | Couch, Radiation Therapy, Powered |
| 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 | JAI |
| CFR Regulation Number | 892.5770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-09 |
| Decision Date | 2004-09-17 |
| Summary: | summary |