The following data is part of a premarket notification filed by Mri Devices Corp. with the FDA for Ifis-sa Integrated Fuctional Imaging System.
| Device ID | K003899 |
| 510k Number | K003899 |
| Device Name: | IFIS-SA INTEGRATED FUCTIONAL IMAGING SYSTEM |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | MRI DEVICES CORP. 1515 PARAMOUNT DR. Waukesha, WI 53186 |
| Contact | William Dinehart |
| Correspondent | William Dinehart 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 | 2000-12-18 |
| Decision Date | 2001-03-15 |