The following data is part of a premarket notification filed by Konica Minolta Medical & Graphic, Inc. with the FDA for Konica Direct Digitizer Regius Model 350.
| Device ID | K013054 |
| 510k Number | K013054 |
| Device Name: | KONICA DIRECT DIGITIZER REGIUS MODEL 350 |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | KONICA MINOLTA MEDICAL & GRAPHIC, INC. 2970 ISHIKAWA-CHO Hachioji-shi Tokyo, JP 192-8505 |
| Contact | Koji Kubo |
| Correspondent | Koji Kubo KONICA MINOLTA MEDICAL & GRAPHIC, INC. 2970 ISHIKAWA-CHO Hachioji-shi Tokyo, JP 192-8505 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-09-11 |
| Decision Date | 2002-03-01 |
| Summary: | summary |