The following data is part of a premarket notification filed by Canon Inc. with the FDA for Mammography Color Display Dp-m3010.
| Device ID | K143718 |
| 510k Number | K143718 |
| Device Name: | Mammography Color Display DP-M3010 |
| Classification | Display, Diagnostic Radiology |
| Applicant | CANON INC. 22-5, Tamura 9-chome Hiratsuka-shi, JP 254-0013 |
| Contact | Masaki Tamura |
| Correspondent | Izumi Maruo MIC INTERNATIONAL CORP. 4-1-17 HONGO Bunkyo-ku, JP 113-0033 |
| Product Code | PGY |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-29 |
| Decision Date | 2015-01-22 |
| Summary: | summary |