The following data is part of a premarket notification filed by Siemens Medical Solution Usa, Inc. with the FDA for Magnetom Avanto Fit.
| Device ID | K190757 |
| 510k Number | K190757 |
| Device Name: | MAGNETOM Avanto Fit |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | Siemens Medical Solution USA, Inc. 40 Liberty Boulevard Mailcode 65-1A Malvern, PA 19355 |
| Contact | Cordell L. Fields |
| Correspondent | Cordell L. Fields Siemens Medical Solution USA, Inc. 40 Liberty Boulevard Mailcode 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 | 2019-03-25 |
| Decision Date | 2019-05-31 |
| Summary: | summary |