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
145–168 of 176
Cleared Sep 19, 1988
MAMMO M
K882133
Ziehm International, Inc.
Radiology · 122d
Cleared Sep 14, 1988
BREAST LESION LOCALIZATION NEEDLE
K881697
Bd Becton Dickinson Vacutainer Systems Preanalytic
Radiology · 148d
Cleared Jun 10, 1988
MAMEX DC MG11
K881505
Orion Corp.
Radiology · 60d
Cleared Jun 10, 1988
MAMEX DC MAG MG12
K881506
Orion Corp.
Radiology · 60d
Cleared May 25, 1988
SENOGRAPHE 600T AND 600TS SENIX HF
K881882
General Electric Co.
Radiology · 21d
Cleared May 02, 1988
MAMMOGRAPHIC X-RAY SYSTEM ATHENA
K880531
Fischer Imaging Corp.
Radiology · 83d
Cleared Mar 21, 1988
MAMMOGRAPHY MOVING GRID BUCKY
K880905
Custom Medical Products, Ltd.
Radiology · 19d
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 Nov 16, 1987
STEREOTIX
K873618
Thomson-Cgr Medical Corp.
Radiology · 69d
Cleared Oct 16, 1987
MAMMOGRAPHIC KVP METER MODEL 232
K873836
Radiation Measurements, Inc.
Radiology · 25d
Cleared Oct 08, 1987
MAMMOGRAPH MAMMOGRAPHIC X-RAY DEVICE
K872734
Palomex Instrumentarium Corp.
Radiology · 91d
Cleared Sep 01, 1987
MICRO MAMMO I MAMMOGRAPHY UNIT
K871048
Amerasia Import-Export, Inc.
Radiology · 168d
Cleared Aug 27, 1987
MAM-CP X-RAY APPARATUS
K872980
Transworld X-Ray Corp.
Radiology · 28d
Cleared May 22, 1987
RF-1 CIRCUIT
K871592
Diagnostic Imaging Specialists Corp.
Radiology · 28d
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 Nov 01, 1985
RMS-1000 A.K.A. RAYTHEON MEDICAL SYSTEMS-1000
K853395
Raytheon Medical Systems
Radiology · 81d
Cleared Jul 19, 1985
MAMMOGRAPH III
K844119
American Medical Imports, Inc.
Radiology · 269d
Cleared Apr 16, 1985
AUSONICS-ALPHA I DIAGNOSTIC X-RAY MAMMOGRAPHY UNIT
K850173
Ausonics Pty , Ltd.
Radiology · 90d