The following data is part of a premarket notification filed by Accuray Incorporated with the FDA for Idms Data Management System.
| Device ID | K161144 |
| 510k Number | K161144 |
| Device Name: | IDMS Data Management System |
| Classification | Accelerator, Linear, Medical |
| Applicant | ACCURAY INCORPORATED 1310 CHESAPEAKE TERRACE Sunnyvale, CA 94089 |
| Contact | Elizabeth Osuna |
| Correspondent | Elizabeth Osuna 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 | 2016-04-22 |
| Decision Date | 2016-06-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811376030085 | K161144 | 000 |