MAGNETOM SKYRA
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 Skyra.
Pre-market Notification Details
| Device ID | K123510 |
| 510k Number | K123510 |
| Device Name: | MAGNETOM SKYRA |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PARKWAY Malvern, PA 19355 |
| Contact | Nadia Sookdeo |
| Correspondent | Nadia Sookdeo SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PARKWAY 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 | 2012-11-13 |
| Decision Date | 2013-05-17 |
| Summary: | summary |
Trademark Results [MAGNETOM SKYRA]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MAGNETOM SKYRA 79083049 3972661 Live/Registered |
Siemens Healthcare GmbH 2010-04-09 |
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