The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Magnetom Combi Suite Neurosurgery For The Magnetom Aera, Magnetom Combi Suite Neurosurgery For The Magnetom Skyra.
| Device ID | K142515 |
| 510k Number | K142515 |
| Device Name: | MAGNETOM Combi Suite Neurosurgery For The MAGNETOM Aera, MAGNETOM Combi Suite Neurosurgery For The MAGNETOM Skyra |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway, Mailcode D02 Malvern, PA 19355 |
| Contact | Cordell L. Fields |
| Correspondent | Cordell L. Fields Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway, Mailcode D02 Malvern, PA 19355 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-08 |
| Decision Date | 2014-10-08 |
| Summary: | summary |