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 |