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 |