MAGNETOM Aera
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 Aera.
Pre-market Notification Details
| Device ID | K182299 |
| 510k Number | K182299 |
| Device Name: | MAGNETOM Aera |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | Siemens Medical Solutions USA Inc. 40 Liberty Boulevard, Mail Code 65-IA Malvern, PA 19355 |
| Contact | Martin Rajchel |
| Correspondent | Martin Rajchel 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 | MOH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-24 |
| Decision Date | 2018-10-26 |
| Summary: | summary |
Trademark Results [MAGNETOM Aera]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MAGNETOM AERA 79077353 4061920 Live/Registered |
Siemens Healthcare GmbH 2009-11-16 |
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