The following data is part of a premarket notification filed by Mri Devices Corp. with the FDA for Dynacad V1.0.
| Device ID | K041286 |
| 510k Number | K041286 |
| Device Name: | DYNACAD V1.0 |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | MRI DEVICES CORP. 1515 PARAMOUNT DR. Waukesha, WI 53186 |
| Contact | Tom Tynes |
| Correspondent | Tom Tynes MRI DEVICES CORP. 1515 PARAMOUNT DR. Waukesha, WI 53186 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-05-13 |
| Decision Date | 2004-07-21 |
| Summary: | summary |