The following data is part of a premarket notification filed by Konica Minolta Medical & Graphic, Inc. with the FDA for Direct Digitizer, Regius Model 190.
| Device ID | K042386 |
| 510k Number | K042386 |
| Device Name: | DIRECT DIGITIZER, REGIUS MODEL 190 |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | KONICA MINOLTA MEDICAL & GRAPHIC, INC. PROGRESS SECTION 319 AKENO, OBATA-CHO Watarai-gun; Mie-ken, JP 519-05 |
| Contact | Shinichi Yamanaka |
| Correspondent | Shinichi Yamanaka KONICA MINOLTA MEDICAL & GRAPHIC, INC. PROGRESS SECTION 319 AKENO, OBATA-CHO Watarai-gun; Mie-ken, JP 519-05 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-02 |
| Decision Date | 2004-12-15 |
| Summary: | summary |