The following data is part of a premarket notification filed by Konica Minolta Medical & Graphic, Inc. with the FDA for Dry Laser Imager, Model Drypro Model 793.
| Device ID | K042133 |
| 510k Number | K042133 |
| Device Name: | DRY LASER IMAGER, MODEL DRYPRO MODEL 793 |
| Classification | Camera, Multi Format, Radiological |
| 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 | LMC |
| CFR Regulation Number | 892.2040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-09 |
| Decision Date | 2004-11-24 |
| Summary: | summary |