The following data is part of a premarket notification filed by Konica Minolta Medical & Graphic, Inc. with the FDA for Dry Laser Imager, Drypro Model 832.
| Device ID | K061999 |
| 510k Number | K061999 |
| Device Name: | DRY LASER IMAGER, DRYPRO MODEL 832 |
| Classification | Camera, Multi Format, Radiological |
| Applicant | KONICA MINOLTA MEDICAL & GRAPHIC, INC. 2970 ISHIKAWA-MACHI Hachioji-shi, Tokyo, JP 192-8505 |
| Contact | Joji Matsushima |
| Correspondent | Joji Matsushima KONICA MINOLTA MEDICAL & GRAPHIC, INC. 2970 ISHIKAWA-MACHI Hachioji-shi, Tokyo, JP 192-8505 |
| Product Code | LMC |
| CFR Regulation Number | 892.2040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-14 |
| Decision Date | 2006-08-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04560141922686 | K061999 | 000 |
| 04560141921641 | K061999 | 000 |