The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Oncor Avant-garde With Coherence Workspaces.
| Device ID | K031764 |
| 510k Number | K031764 |
| Device Name: | ONCOR AVANT-GARDE WITH COHERENCE WORKSPACES |
| Classification | Accelerator, Linear, Medical |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 4040 NELSON AVE. Concord, CA 94520 |
| Contact | Ken Nehmer |
| Correspondent | Ken Nehmer SIEMENS MEDICAL SOLUTIONS USA, INC. 4040 NELSON AVE. Concord, CA 94520 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-09 |
| Decision Date | 2003-09-05 |
| Summary: | summary |