The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Syngo Mr B17.
| Device ID | K082427 |
| 510k Number | K082427 |
| Device Name: | SYNGO MR B17 |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PKWY. Malvern, PA 19355 -1406 |
| Contact | Elizabeth Lazaro |
| Correspondent | Elizabeth Lazaro SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PKWY. Malvern, PA 19355 -1406 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-22 |
| Decision Date | 2008-11-07 |
| Summary: | summary |