The following data is part of a premarket notification filed by Siemens Medical Solutions Usa Inc. with the FDA for Magnetom Aera; Magnetom Skyra.
| Device ID | K101347 |
| 510k Number | K101347 |
| Device Name: | MAGNETOM AERA; MAGNETOM SKYRA |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA INC. 53 VALLEY STREAM PARKWAY Malvern, PA 19533 |
| Contact | Kim Rendon |
| Correspondent | Kim Rendon SIEMENS MEDICAL SOLUTIONS USA INC. 53 VALLEY STREAM PARKWAY Malvern, PA 19533 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-05-13 |
| Decision Date | 2010-10-01 |
| Summary: | summary |