The following data is part of a premarket notification filed by Siemens Medical Solutions, Inc. with the FDA for Magnetom Systems - I-class And T-class Releases.
| Device ID | K062454 |
| 510k Number | K062454 |
| Device Name: | MAGNETOM SYSTEMS - I-CLASS AND T-CLASS RELEASES |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | SIEMENS MEDICAL SOLUTIONS, INC. 51 VALLEY STREAM PARKWAY Malvern, PA 19355 |
| Contact | Judith Campbell |
| Correspondent | Judith Campbell SIEMENS MEDICAL SOLUTIONS, 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 | 2006-08-22 |
| Decision Date | 2006-11-03 |
| Summary: | summary |