The following data is part of a premarket notification filed by Siemens Medical Solution with the FDA for Magnetom Symphony A Tim System.
Device ID | K050199 |
510k Number | K050199 |
Device Name: | MAGNETOM SYMPHONY A TIM SYSTEM |
Classification | System, Nuclear Magnetic Resonance Imaging |
Applicant | SIEMENS MEDICAL SOLUTION 51 VALLEY STREAM PKWY. Malvern, PA 19355 |
Contact | Ana Ladino |
Correspondent | Ana Ladino SIEMENS MEDICAL SOLUTION 51 VALLEY STREAM PKWY. Malvern, PA 19355 |
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 | 2005-02-18 |
Summary: | summary |