MAGNETOM Free.Max
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 Free.max.
Pre-market Notification Details
| Device ID | K210611 |
| 510k Number | K210611 |
| Device Name: | MAGNETOM Free.Max |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, Mailcode 65-1A Malvern, PA 19355 |
| Contact | Andrew Turner |
| Correspondent | Andrew Turner Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, Mailcode 65-1A Malvern, PA 19355 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-01 |
| Decision Date | 2021-07-01 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869281940 | K210611 | 000 |
| 04056869281933 | K210611 | 000 |
| 04056869281896 | K210611 | 000 |
| 04056869281858 | K210611 | 000 |
| 04056869281742 | K210611 | 000 |
| 04056869267258 | K210611 | 000 |
| 04056869267241 | K210611 | 000 |
| 04056869267234 | K210611 | 000 |
| 04056869267227 | K210611 | 000 |
Trademark Results [MAGNETOM Free.Max]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MAGNETOM FREE.MAX 79309401 not registered Live/Pending |
Siemens Healthcare GmbH 2021-02-03 |
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