The following data is part of a premarket notification filed by Siemens Medical Solutions Usa Inc. with the FDA for Magnetom Aera.
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 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
MAGNETOM AERA 79077353 4061920 Live/Registered |
Siemens Healthcare GmbH 2009-11-16 |