The following data is part of a premarket notification filed by Konica Minolta Healthcare Americas, Inc with the FDA for Kdr Au-ddr System Advanced U-arm With Dynamic Digital Radiography, Kdr Au System Advanced U-arm With Static Digital Radiography.
| Device ID | K193225 |
| 510k Number | K193225 |
| Device Name: | KDR AU-DDR System Advanced U-Arm With Dynamic Digital Radiography, KDR AU System Advanced U-Arm With Static Digital Radiography |
| Classification | System, X-ray, Stationary |
| Applicant | Konica Minolta Healthcare Americas, Inc 2217 US Highway 70 East Gamer, NC 27529 |
| Contact | Jan Maniscalco |
| Correspondent | Jan Maniscalco Konica Minolta Healthcare Americas, Inc 2217 US Highway 70 East Gamer, NC 27529 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-22 |
| Decision Date | 2020-01-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817100021268 | K193225 | 000 |