The following data is part of a premarket notification filed by Konica Minolta Healthcare Americas, Inc. with the FDA for Universal Dr 1748.
| Device ID | K214030 |
| 510k Number | K214030 |
| Device Name: | Universal DR 1748 |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | Konica Minolta Healthcare Americas, Inc. 2217 US Highway 70 East Garner, NC 27529 |
| Contact | Jan Maniscalco |
| Correspondent | Jan Maniscalco Konica Minolta Healthcare Americas, Inc. 2217 US Highway 70 East Garner, NC 27529 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-23 |
| Decision Date | 2022-01-21 |