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 |