The following data is part of a premarket notification filed by Orion Corp. with the FDA for Mamex Dc Mg11.
| Device ID | K881505 |
| 510k Number | K881505 |
| Device Name: | MAMEX DC MG11 |
| Classification | System, X-ray, Mammographic |
| Applicant | ORION CORP. 3 WILLOW RIDGE CIRCLE Conroe, TX 77304 |
| Contact | John R Hogan |
| Correspondent | John R Hogan ORION CORP. 3 WILLOW RIDGE CIRCLE Conroe, TX 77304 |
| Product Code | IZH |
| CFR Regulation Number | 892.1710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-11 |
| Decision Date | 1988-06-10 |