The following data is part of a premarket notification filed by Siemens Medical Solutions with the FDA for Magnetom C! Mr System.
| Device ID | K043030 |
| 510k Number | K043030 |
| Device Name: | MAGNETOM C! MR SYSTEM |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | SIEMENS MEDICAL SOLUTIONS 51 VALLEY STREAM PARKWAY E50 Malvern, PA 19355 |
| Contact | Nealie Hartman |
| Correspondent | Nealie Hartman SIEMENS MEDICAL SOLUTIONS 51 VALLEY STREAM PARKWAY E50 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 | 2004-11-03 |
| Decision Date | 2004-12-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869049717 | K043030 | 000 |
| 04056869049687 | K043030 | 000 |
| 04056869038902 | K043030 | 000 |
| 04056869038896 | K043030 | 000 |
| 04056869038889 | K043030 | 000 |