The following data is part of a premarket notification filed by Siemens Medical Solutions Usa Inc. with the FDA for Magnetom Terra.
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 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04260487680454 | K183222 | 000 |
04260487680324 | K183222 | 000 |
04260487680287 | K183222 | 000 |
04260487680164 | K183222 | 000 |
04260487680157 | K183222 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
MAGNETOM TERRA 79179645 4975702 Live/Registered |
Siemens Healthcare GmbH 2015-11-27 |