The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Magnetom Avanto-fit, Magnetom Skyra-fit.
| Device ID | K130885 |
| 510k Number | K130885 |
| Device Name: | MAGNETOM AVANTO-FIT, MAGNETOM SKYRA-FIT |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 757 A ARNOLD DRIVE Martinez, CA 94553 |
| Contact | Christine Dunbar |
| Correspondent | Christine Dunbar SIEMENS MEDICAL SOLUTIONS USA, INC. 757 A ARNOLD DRIVE Martinez, CA 94553 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-29 |
| Decision Date | 2013-05-17 |
| Summary: | summary |