The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Specialty Coils For Magnetom Aera 1.5t & Magnetim Skyra 3t Mr Systems.
| Device ID | K103275 |
| 510k Number | K103275 |
| Device Name: | SPECIALTY COILS FOR MAGNETOM AERA 1.5T & MAGNETIM SKYRA 3T MR SYSTEMS |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PKWY. Malvern, PA 19355 -1406 |
| Contact | Alicia Bustos-juergensen |
| Correspondent | Alicia Bustos-juergensen SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PKWY. Malvern, PA 19355 -1406 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-05 |
| Decision Date | 2011-01-11 |
| Summary: | summary |