The following data is part of a premarket notification filed by Orion Corp. with the FDA for Mamex Dc S Sl10/mg14.
| Device ID | K874040 |
| 510k Number | K874040 |
| Device Name: | MAMEX DC S SL10/MG14 |
| Classification | System, X-ray, Mammographic |
| Applicant | ORION CORP. P.O. BOX 425 20101 Turku, FI |
| Contact | Ensio Koskennurmi |
| Correspondent | Ensio Koskennurmi ORION CORP. P.O. BOX 425 20101 Turku, FI |
| Product Code | IZH |
| CFR Regulation Number | 892.1710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-10-05 |
| Decision Date | 1987-11-23 |