The following data is part of a premarket notification filed by Medis Medical Imaging Systems, B.v. with the FDA for Mri- Magnetic Resonance Analytical Software System.
| Device ID | K994283 |
| 510k Number | K994283 |
| Device Name: | MRI- MAGNETIC RESONANCE ANALYTICAL SOFTWARE SYSTEM |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | MEDIS MEDICAL IMAGING SYSTEMS, B.V. POORTGEBOUW RIJNSBURGERWEG 10 Leiden, NL 2333 Aa |
| Contact | J.i. Hollander |
| Correspondent | J.i. Hollander MEDIS MEDICAL IMAGING SYSTEMS, B.V. POORTGEBOUW RIJNSBURGERWEG 10 Leiden, NL 2333 Aa |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-20 |
| Decision Date | 2000-08-30 |
| Summary: | summary |