The following data is part of a premarket notification filed by Konica Minolta Medical & Graphic, Inc. with the FDA for Regius Console Cs-2000 And Regius Console Cs-3000, Medical Image Processing Workstation.
| Device ID | K051523 |
| 510k Number | K051523 |
| Device Name: | REGIUS CONSOLE CS-2000 AND REGIUS CONSOLE CS-3000, MEDICAL IMAGE PROCESSING WORKSTATION |
| Classification | System, Image Processing, Radiological |
| Applicant | KONICA MINOLTA MEDICAL & GRAPHIC, INC. 319 AKENO, OBATA-CHO Watarai-gun, Mie-ken, JP 519-05 |
| Contact | Shinichi Yamanaka |
| Correspondent | Shinichi Yamanaka KONICA MINOLTA MEDICAL & GRAPHIC, INC. 319 AKENO, OBATA-CHO Watarai-gun, Mie-ken, JP 519-05 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-08 |
| Decision Date | 2005-07-20 |
| Summary: | summary |