The following data is part of a premarket notification filed by Minxray, Inc. with the FDA for Minxray 500m Mammographic System.
| Device ID | K854510 |
| 510k Number | K854510 |
| Device Name: | MINXRAY 500M MAMMOGRAPHIC SYSTEM |
| Classification | System, X-ray, Mammographic |
| Applicant | MINXRAY, INC. 1732 CENTRAL ST. Evanston, IL 60201 |
| Contact | Keith R Kretchmer |
| Correspondent | Keith R Kretchmer MINXRAY, INC. 1732 CENTRAL ST. Evanston, IL 60201 |
| Product Code | IZH |
| CFR Regulation Number | 892.1710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-11-12 |
| Decision Date | 1986-01-01 |