IZH · Class II · 21 CFR 892.1710

FDA Product Code IZH: System, X-ray, Mammographic

Leading manufacturers include Planmed OY, Lorad Corp. and Elscint, Inc..

176
Total
176
Cleared
114d
Avg days
1977
Since
176 devices
169–176 of 176
Cleared Mar 26, 1985
SAND S MB12 MAMMOGRAPHY MOVING GRID BUCKY
K850614
S & S X-Ray Products, Inc.
Radiology · 39d
Cleared Nov 27, 1984
MEI MAMMOGRAPHY SYS MX-2049
K843437
Moti Enterprises, Inc.
Radiology · 84d
Cleared Jul 17, 1984
LORAD
K842102
Lorad Medical Systems, Inc.
Radiology · 53d
Cleared Jun 26, 1984
UNIMACS, PATENT PENDING UNIVERSAL MAM
K841774
Technical Devices For Medicine
Radiology · 57d
Cleared Oct 28, 1983
MAMMOGRAPHIC S-RAY SYSTEM
K833243
Xerox Medical Systems
Radiology · 71d
Cleared Sep 29, 1983
XEROX 120 SYS MAMMOGRAPHIC X-RAY
K832733
Xerox Medical Systems
Radiology · 41d
Cleared Mar 21, 1979
MAMMOGRAPHY SYSTEM AND CASSETTE
K790273
Agfa-Gevaert, Inc.
Radiology · 41d
Cleared Aug 03, 1977
X-RAY DEVICE, MAMMOGRAPHIC DIAGNOSTIC
K770693
Xonics Medical Systems, Inc.
Radiology · 112d