IZH · Class II · 21 CFR 892.1710

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

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

176
Total
176
Cleared
114d
Avg days
1977
Since
176 devices
121–144 of 176
Cleared Dec 02, 1991
MAMMOMAT C3 AND 3 MAMMOGRAPHIC X-RAY SYSTEM
K914328
Siemens Medical Solutions USA, Inc.
Radiology · 66d
Cleared Sep 23, 1991
VARIOUS MODELS OF DAYLIGHT CASSETTE HOLDERS
K910111
Instrumentarium Imaging, Inc.
Radiology · 256d
Cleared Sep 19, 1991
MAM-3RM-A MAMMOGRAPHIC X-RAY SYSTEM
K912974
Elscint, Inc.
Radiology · 73d
Cleared May 30, 1991
ALPHA III PLUS AND MODEL P2500F/101 W/OPTIONAL
K896596
Instrumentarium Imaging, Inc.
Radiology · 555d
Cleared Apr 18, 1991
PLANMED SOPHIE
K904953
Planmeca USA, Inc.
Radiology · 164d
Cleared Mar 07, 1991
MAMEX DC AMI SL12/MG15
K905748
Soredex, Inc.
Radiology · 71d
Cleared Nov 15, 1990
AMI MAMMOSPOT
K903651
American Mammographics, Inc.
Radiology · 97d
Cleared Nov 15, 1990
MAMMOSPOT 3 AND MAMMOSPOT 8
K904517
American Mammographics, Inc.
Radiology · 43d
Cleared Jul 03, 1990
GIOTTO MAMMOGRAPHY HF
K901558
Medical Device Marketing Network, Inc.
Radiology · 91d
Cleared Jun 06, 1990
X-RAY TUBE HOUSING ASSEMBLY, VARIOUS MODELS
K901997
Comet Ltd. C/O Radiology Resources, Inc.
Radiology · 35d
Cleared Mar 28, 1990
ATHENA-HF MAMMOGRAPHIC X-RAY SYSTEM
K900989
Fischer Imaging Corp.
Radiology · 26d
Cleared Jan 31, 1990
CYTOGUIDE FOR USE W/THE PHILMEDISYST MAMMODIAG UC
K896609
Philips Medical Systems North America, Inc.
Radiology · 175d
Cleared Nov 17, 1989
TEC 2750 PHOENIX DEDICATED MAMMOGRAPHIC SYSTEM
K892342
Bay Shore Medical Equipment Corp.
Radiology · 226d
Cleared May 05, 1989
STEREOTACTIC BIOPSY ATTACHMENT
K884107
Siemens Medical Solutions USA, Inc.
Radiology · 218d
Cleared May 03, 1989
MAMMOMAT C
K890784
Siemens Medical Solutions USA, Inc.
Radiology · 77d
Cleared Apr 26, 1989
CYTOGUIDE
K885020
Philips Medical Systems North America, Inc.
Radiology · 142d
Cleared Apr 07, 1989
SPECBOARD
K891090
Macbrud Corp. Medical Div.
Radiology · 32d
Cleared Mar 23, 1989
MODEL ESP-200 MAMMOGRAPHIC SYSTEM
K884345
Acoma Medical Imaging, Inc.
Radiology · 160d
Cleared Mar 14, 1989
THE PATHFINDER SYSTEM
K890483
Denmark Assoc.
Radiology · 42d
Cleared Mar 09, 1989
RESUSCITATOR'S GUARD SUCTION CONTROL SYSTEM
K884917
Amg Medical Equipments, Inc.
Radiology · 101d
Cleared Mar 09, 1989
MICRO-FINE HIGH FREQ. MOBILE MAMMO. SYSTEM MF-150
K885135
Bennett X-Ray Corp.
Radiology · 84d
Cleared Jan 06, 1989
MAM-2 MICROFOCUS MAMMOGRAPHY SYSTEM W/MAGNIFI.
K884676
Elscint, Inc.
Radiology · 59d
Cleared Jan 06, 1989
MAM LS-3 MICROFOCUS MAMMOGRAPHY SYSTEM W/MAGNIFI.
K884677
Elscint, Inc.
Radiology · 59d
Cleared Nov 07, 1988
STEREOTACTIC BREAST LESION LOCALIZATION ACCESSORY
K882875
Lorad Medical Systems, Inc.
Radiology · 119d