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
73–96 of 176
Cleared Sep 11, 1992
MOBILE ATHENA HF
K922454
Fischer Imaging Corp.
Radiology · 108d
Cleared Sep 10, 1992
MAMMOSCAN
K923061
Fischer Imaging Corp.
Radiology · 77d
Cleared Aug 03, 1992
TILTING MAG
K921896
Continental X-Ray Corp.
Radiology · 103d
Cleared Jul 28, 1992
CYTOGUIDE STEREOTACTIC BIOPSY SYSTEM MODEL MF-CYTO
K915201
Bennett X-Ray Corp.
Radiology · 253d
Cleared Feb 04, 1992
AVIVA MAMMOGRAPHIC X-RAY SYSTEM
K915748
Elscint, Inc.
Radiology · 43d
Cleared Jan 06, 1992
SENOGRAPHE DMR/SMR/DM
K913418
General Electric Co.
Radiology · 159d
Cleared Dec 20, 1991
PHILIPS MAMMODIAGNOST BC
K913845
Philips Medical Systems, Inc.
Radiology · 114d
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 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 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 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 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