The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Magnetom Aera With Software Syngo Mr E11a, Magnetom Skyra With Software Syngo Mr E11a, Magnetom Skyra With 24 Rf Channel.
| Device ID | K141977 |
| 510k Number | K141977 |
| Device Name: | MAGNETOM AERA WITH SOFTWARE SYNGO MR E11A, MAGNETOM SKYRA WITH SOFTWARE SYNGO MR E11A, MAGNETOM SKYRA WITH 24 RF CHANNEL |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PARKWAY Malvern, PA 19355 |
| Contact | Nadia Sookdeo |
| Correspondent | Nadia Sookdeo SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PARKWAY 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 | 2014-07-21 |
| Decision Date | 2014-11-19 |
| Summary: | summary |