IZH · Class II · 21 CFR 892.1710

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

Leading manufacturers include Planmed OY, Elscint, Inc. and Fischer Imaging Corp..

176
Total
176
Cleared
114d
Avg days
1977
Since
176 devices
97–120 of 176
Cleared Feb 12, 1988
SHIMADZU MAMMOGRAPHIC STAND MR-30
K875377
Shimadzu Precision Instruments, Inc.
Radiology · 43d
Cleared Nov 23, 1987
MAMEX DC S SL10/MG14
K874040
Orion Corp.
Radiology · 49d
Cleared Jan 30, 1987
ALPHA II DIAGNOSTIC X-RAY
K864958
Ausonics Pty , Ltd.
Radiology · 43d
Cleared Dec 15, 1986
FISCHER PPS/MAMMOTEST MAMMOGRAPHY SYSTEM
K861692
Fischer Imaging Corp.
Radiology · 227d
Cleared Oct 14, 1986
ALPHA S/D DIAGNOSTIC X-RAY MAMMOGRAPHY UNIT
K863710
Ausonics Pty , Ltd.
Radiology · 21d
Cleared Mar 06, 1986
TEC 2720 MAMEX DC MAG
K854203
Tecnomed, Inc.
Radiology · 141d
Cleared Mar 06, 1986
ISO-MAMMO
K860129
Philips Medical Systems (Cleveland), Inc.
Radiology · 51d
Cleared Jan 01, 1986
MINXRAY 500M MAMMOGRAPHIC SYSTEM
K854510
Minxray, Inc.
Radiology · 50d
Cleared Apr 16, 1985
AUSONICS-ALPHA I DIAGNOSTIC X-RAY MAMMOGRAPHY UNIT
K850173
Ausonics Pty , Ltd.
Radiology · 90d