The following data is part of a premarket notification filed by Siemens Medical Solutions Usa Inc. with the FDA for Magnetom Sola, Magnetom Altea And Magnetom Sola Fit.
| Device ID | K192496 |
| 510k Number | K192496 |
| Device Name: | Magnetom Sola, Magnetom Altea And Magnetom Sola Fit |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | Siemens Medical Solutions USA Inc. 40 Liberty Boulevard, Mail Code 65-IA Malvern, PA 19355 |
| Contact | Cordell L Fields |
| Correspondent | Cordell L Fields Siemens Medical Solutions USA Inc. 40 Liberty Boulevard, Mail Code 65-IA 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 | 2019-09-11 |
| Decision Date | 2020-02-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869245195 | K192496 | 000 |
| 04056869230719 | K192496 | 000 |
| 04056869230726 | K192496 | 000 |
| 04056869217864 | K192496 | 000 |