MAGNETOM Terra
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 Terra.
Pre-market Notification Details
| Device ID | K183222 |
| 510k Number | K183222 |
| Device Name: | MAGNETOM Terra |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | Siemens Medical Solutions USA Inc. 40 Liberty Boulevard Malvern, PA 19355 |
| Contact | Milind Dhamankar |
| Correspondent | Milind Dhamankar Siemens Medical Solutions USA Inc. 40 Liberty Boulevard 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 | 2018-11-20 |
| Decision Date | 2019-02-15 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260487680454 | K183222 | 000 |
| 04260487680324 | K183222 | 000 |
| 04260487680287 | K183222 | 000 |
| 04260487680164 | K183222 | 000 |
| 04260487680157 | K183222 | 000 |
Trademark Results [MAGNETOM Terra]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MAGNETOM TERRA 79179645 4975702 Live/Registered |
Siemens Healthcare GmbH 2015-11-27 |
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