The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Artistetm Solution With Sys Vcio.
| Device ID | K121295 |
| 510k Number | K121295 |
| Device Name: | ARTISTETM SOLUTION WITH SYS VCIO |
| Classification | Accelerator, Linear, Medical |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 4040 NELSON AVE. Concord, CA 94520 |
| Contact | Christine Dunbar |
| Correspondent | Christine Dunbar 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 | 2012-04-30 |
| Decision Date | 2012-06-27 |
| Summary: | summary |