The following data is part of a premarket notification filed by Siemens Ag, Medical Solutions with the FDA for Sienet Cosmos.
| Device ID | K033831 | 
| 510k Number | K033831 | 
| Device Name: | SIENET COSMOS | 
| Classification | System, Image Processing, Radiological | 
| Applicant | SIEMENS AG, MEDICAL SOLUTIONS HENKESTRASSE 127 Erlangen, DE D-91052 | 
| Contact | Eva-maria Reiter | 
| Correspondent | Stefan Preiss TUV AMERICA, INC. 1775 OLD HIGHWAY 8 New Brighton, MN 55112 -1891 | 
| Product Code | LLZ | 
| CFR Regulation Number | 892.2050 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Traditional | 
| 3rd Party Reviewed | Yes | 
| Combination Product | No | 
| Date Received | 2003-12-10 | 
| Decision Date | 2003-12-19 | 
| Summary: | summary | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  SIENET COSMOS  79002436  3032422 Dead/Cancelled | Siemens Aktiengesellschaft 2004-04-23 |