The following data is part of a premarket notification filed by Medis Medical Imaging Systems, B.v. with the FDA for Qplaque Mr.
| Device ID | K073156 |
| 510k Number | K073156 |
| Device Name: | QPLAQUE MR |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | MEDIS MEDICAL IMAGING SYSTEMS, B.V. 9 SCHUTTERSVELD P.O. BOX 384 Leiden, NL 2316 Xg |
| Contact | J.i. Hollander |
| Correspondent | J.i. Hollander MEDIS MEDICAL IMAGING SYSTEMS, B.V. 9 SCHUTTERSVELD P.O. BOX 384 Leiden, NL 2316 Xg |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-11-08 |
| Decision Date | 2008-03-04 |
| Summary: | summary |