The following data is part of a premarket notification filed by Siemens Medical Solutions Usa Inc. with the FDA for Syngo Brevis.
| Device ID | K090038 | 
| 510k Number | K090038 | 
| Device Name: | SYNGO BREVIS | 
| Classification | System, Nuclear Magnetic Resonance Imaging | 
| Applicant | SIEMENS MEDICAL SOLUTIONS USA INC. 51 VALLEY STREAM PARKWAY Malvern, PA 19355 | 
| Contact | Judith Campbell | 
| Correspondent | Judith Campbell SIEMENS MEDICAL SOLUTIONS USA INC. 51 VALLEY STREAM PARKWAY Malvern, PA 19355 | 
| Product Code | LNH | 
| CFR Regulation Number | 892.1000 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Traditional | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 2009-01-06 | 
| Decision Date | 2009-04-28 | 
| Summary: | summary | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  SYNGO BREVIS  79079496  3924868 Live/Registered | Siemens Healthcare GmbH 2010-01-25 |