The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Magnetom C! Mr System.
| Device ID | K041111 |
| 510k Number | K041111 |
| Device Name: | MAGNETOM C! MR SYSTEM |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PKWY. Malvern, PA 19355 -1406 |
| Contact | Nealie Hartman |
| Correspondent | Nealie Hartman SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PKWY. Malvern, PA 19355 -1406 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-28 |
| Decision Date | 2004-07-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869049700 | K041111 | 000 |
| 04056869038872 | K041111 | 000 |
| 04056869038865 | K041111 | 000 |
| 04056869038858 | K041111 | 000 |
| 04056869038841 | K041111 | 000 |
| 04056869038834 | K041111 | 000 |
| 04056869038827 | K041111 | 000 |
| 04056869038810 | K041111 | 000 |
| 04056869038803 | K041111 | 000 |
| 04056869038797 | K041111 | 000 |
| 04056869038780 | K041111 | 000 |
| 04056869038773 | K041111 | 000 |
| 04056869039169 | K041111 | 000 |
| 04056869042299 | K041111 | 000 |
| 04056869049571 | K041111 | 000 |
| 04056869049694 | K041111 | 000 |
| 04056869049670 | K041111 | 000 |
| 04056869049663 | K041111 | 000 |
| 04056869049656 | K041111 | 000 |
| 04056869049649 | K041111 | 000 |
| 04056869049632 | K041111 | 000 |
| 04056869049625 | K041111 | 000 |
| 04056869049618 | K041111 | 000 |
| 04056869049601 | K041111 | 000 |
| 04056869049595 | K041111 | 000 |
| 04056869049588 | K041111 | 000 |
| 04056869038766 | K041111 | 000 |