The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Magnetom Sempra With Syngo Mr E11s.
| Device ID | K163211 |
| 510k Number | K163211 |
| Device Name: | MAGNETOM Sempra With Syngo MR E11S |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | Siemens Medical Solutions USA, Inc. 65 Valley Steam Pkwy. Malvern, PA 19355 |
| Contact | Cordell L Fields |
| Correspondent | Cordell L Fields Siemens Medical Solutions USA, Inc. 65 Valley Steam Pkwy. Malvern, PA 19355 |
| Product Code | LNH |
| Subsequent Product Code | LNI |
| Subsequent Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-16 |
| Decision Date | 2017-01-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869044538 | K163211 | 000 |
| 04056869044521 | K163211 | 000 |