The following data is part of a premarket notification filed by Konica Minolta Medical & Graphic, Inc. with the FDA for Konica Minolta Xpress Digital Mammography System.
| Device ID | K110717 |
| 510k Number | K110717 |
| Device Name: | KONICA MINOLTA XPRESS DIGITAL MAMMOGRAPHY SYSTEM |
| Classification | Full Field Digital, System, X-ray, Mammographic |
| Applicant | KONICA MINOLTA MEDICAL & GRAPHIC, INC. 25 WALNUT STREET Monroe, CT 06468 |
| Contact | Jillian M Reed |
| Correspondent | Jillian M Reed KONICA MINOLTA MEDICAL & GRAPHIC, INC. 25 WALNUT STREET Monroe, CT 06468 |
| Product Code | MUE |
| CFR Regulation Number | 892.1715 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-15 |
| Decision Date | 2011-12-23 |
| Summary: | summary |