MAGNETOM Sola
System, Nuclear Magnetic Resonance Imaging
Siemens Medical Solutions USA, Inc.
The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Magnetom Sola.
Pre-market Notification Details
| Device ID | K181322 |
| 510k Number | K181322 |
| Device Name: | MAGNETOM Sola |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | Siemens Medical Solutions USA, Inc. 65 Valley Stream Parkway 65-1A Malvern, PA 19355 |
| Contact | Cordell L. Fields |
| Correspondent | Cordell L. Fields Siemens Medical Solutions USA, Inc. 65 Valley Stream Parkway 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 | 2018-05-18 |
| Decision Date | 2018-10-05 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869164809 | K181322 | 000 |
Trademark Results [MAGNETOM Sola]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MAGNETOM SOLA 79235357 not registered Live/Pending |
Siemens Healthcare GmbH 2018-05-18 |
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