The following data is part of a premarket notification filed by Nrt-nordisk Rontgen Teknik A/s with the FDA for Ge Precision Mpi.
| Device ID | K033486 |
| 510k Number | K033486 |
| Device Name: | GE PRECISION MPI |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | NRT-NORDISK RONTGEN TEKNIK A/S BIRKEGAARDSVEJ 16 Hasselager, DK 8361 |
| Contact | Jan Malling |
| Correspondent | Heinz-jorg Steneberg TUV RHEINLAND OF NORTH AMERICA, INC. 1279 QUARRY LANE, SUITE A Pleasanton, CA 94566 |
| Product Code | OWB |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-11-04 |
| Decision Date | 2003-11-19 |
| Summary: | summary |