The following data is part of a premarket notification filed by General Electric Co. with the FDA for Senographe Dmr/smr/dm.
| Device ID | K913418 |
| 510k Number | K913418 |
| Device Name: | SENOGRAPHE DMR/SMR/DM |
| Classification | System, X-ray, Mammographic |
| Applicant | GENERAL ELECTRIC CO. P.O. BOX 414 Milwaukee, WI 53201 |
| Contact | Larry A Kroger |
| Correspondent | Larry A Kroger GENERAL ELECTRIC CO. P.O. BOX 414 Milwaukee, WI 53201 |
| Product Code | IZH |
| CFR Regulation Number | 892.1710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-31 |
| Decision Date | 1992-01-06 |