The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Magnetom Trio A Tim System.
Device ID | K050200 |
510k Number | K050200 |
Device Name: | MAGNETOM TRIO A TIM SYSTEM |
Classification | System, Nuclear Magnetic Resonance Imaging |
Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PKWY. Malvern, PA 19355 -1406 |
Contact | Ana Ladino |
Correspondent | Ana Ladino SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PKWY. Malvern, PA 19355 -1406 |
Product Code | LNH |
CFR Regulation Number | 892.1000 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-01-28 |
Decision Date | 2005-02-28 |
Summary: | summary |