The following data is part of a premarket notification filed by Mri Devices Corp. with the FDA for Model #qsc-200, 20cm. Quadrature Shoulder Coil.
| Device ID | K922000 |
| 510k Number | K922000 |
| Device Name: | MODEL #QSC-200, 20CM. QUADRATURE SHOULDER COIL |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | MRI DEVICES CORP. P.O. BOX 170 Hartland, WI 53029 |
| Contact | Thomas Schubert |
| Correspondent | Thomas Schubert MRI DEVICES CORP. P.O. BOX 170 Hartland, WI 53029 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-29 |
| Decision Date | 1992-07-28 |