Recognized a 510(k)/PMA number — showing its clearance record and devices.
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| DxTx Medical 1.5T eCoil Imaging Device (for GE) | M64ERA8-P | DXTX MEDICAL INC | MOS | 00850011472224 |
| DxTx Medical 1.5T eCoil Imaging Device (for GE) | M64ERA8-HD | DXTX MEDICAL INC | MOS | 00850011472071 |
| MEDRAD® 1.5T eCoil Interface Device (for GE) | M64ERA8-HD | BAYER MEDICAL CARE INC. | MOS | 00616258009001 |