The following data is part of a premarket notification filed by Elscint, Inc. with the FDA for Mam-2 Microfocus Mammography System W/magnifi..
| Device ID | K884676 |
| 510k Number | K884676 |
| Device Name: | MAM-2 MICROFOCUS MAMMOGRAPHY SYSTEM W/MAGNIFI. |
| Classification | System, X-ray, Mammographic |
| Applicant | ELSCINT, INC. 751 EXPRESSWAY DR. Itasca, IL 60143 |
| Contact | Robert E Kenney |
| Correspondent | Robert E Kenney ELSCINT, INC. 751 EXPRESSWAY DR. Itasca, IL 60143 |
| Product Code | IZH |
| CFR Regulation Number | 892.1710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-11-08 |
| Decision Date | 1989-01-06 |