The following data is part of a premarket notification filed by Siemens Medical Solutions, Inc. with the FDA for Magnetom Systems With Syngo Expert - I Option.
| Device ID | K052423 |
| 510k Number | K052423 |
| Device Name: | MAGNETOM SYSTEMS WITH SYNGO EXPERT - I OPTION |
| 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 | 2005-09-02 |
| Decision Date | 2006-01-13 |
| Summary: | summary |