The following data is part of a premarket notification filed by Siemens Medical Solutions, Inc. with the FDA for Magnetom Avantofit, Magnetom Skyrafit.
| Device ID | K162102 |
| 510k Number | K162102 |
| Device Name: | MAGNETOM Avantofit, MAGNETOM Skyrafit |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | SIEMENS MEDICAL SOLUTIONS, INC. 40 LIBERTY BOULEVARD MAIL CODE 65-1A Malvern, PA 19355 |
| Contact | John Urtz |
| Correspondent | Cordell Fields SIEMENS MEDICAL SOLUTIONS, INC. 40 LIBERTY BOULEVARD MAIL CODE 65-1A 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 | 2016-07-29 |
| Decision Date | 2016-11-22 |
| Summary: | summary |