Summit Industries Inc.

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
8
Inspections
9
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0468-2015Class IIThe J700 Floor Mounted Tube Stand (FMTS) is intended to support and position the diagnostic x-ray tuOctober 28, 2014

Recent 510(k) Clearances

K-NumberDeviceDate
K173823Amrad Medical AAU Digital Radiography System; Amrad Medical AAU Plus Digital Radiography System; AmrFebruary 9, 2018
K153119Amrad Medical OTS Digital Radiography System, Amrad Medical DFMTS Digital Radiography SystemAmrad MeMarch 14, 2016
K874908C900 X-RAY FILM PROCESSORFebruary 12, 1988
K874687COLLI-MATETM MODEL NO. B800December 30, 1987
K851440RDIOGRAPHIC WALL HOLDER OR FILM RECEPTORJune 5, 1985
K850198FLOOR TO WALL OR FLOOR TO CEILING TUBESTAND;RADIOGMay 14, 1985
K850117XMA 325 (X-RAY GENERATOR)April 9, 1985
K850118XMA INTEGRATED TABLEApril 9, 1985