The following data is part of a premarket notification filed by Konica Minolta Medical & Graphic, Inc. with the FDA for Regius Model 170 Direct Digitizer.
| Device ID | K051998 |
| 510k Number | K051998 |
| Device Name: | REGIUS MODEL 170 DIRECT DIGITIZER |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | KONICA MINOLTA MEDICAL & GRAPHIC, INC. 2970 ISHIKAWA-MACHI Hachioji-shi, Tokyo, JP 192-8505 |
| Contact | Masafumi Saito |
| Correspondent | Masafumi Saito KONICA MINOLTA MEDICAL & GRAPHIC, INC. 2970 ISHIKAWA-MACHI 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 | 2005-07-25 |
| Decision Date | 2005-11-03 |
| Summary: | summary |