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
97–120 of 176
Cleared May 04, 1994
SYSTEM, X-RAY, MAMOGRAPHIC
K936161
Technowipe
Radiology · 128d
Cleared Apr 28, 1994
BENNETT MAMMOGRAPHY POSITIONING CHAIR MODEL NO. M-PCH
K940701
Bennett X-Ray Corp.
Radiology · 71d
Cleared Apr 07, 1994
MOBILE SOPHIE MODIFICATION
K934373
Planmed OY
Radiology · 211d
Cleared Jan 31, 1994
LORAD M-IIE MODIFICATION
K934748
Lorad Corp.
Radiology · 119d
Cleared Jan 31, 1994
LORAD D-550
K934870
Lorad Corp.
Radiology · 111d
Cleared Jan 28, 1994
LORAD M-III
K934625
Lorad Corp.
Radiology · 123d
Cleared Sep 20, 1993
CHENOWETH-FRANK RADIOPATHOLOGICAL GRID
K933754
Cook, Inc.
Radiology · 48d
Cleared Aug 23, 1993
AVIVA F22/MAM-CH22 W/OPTIONAL CYTOGUIDE BIOPSY SYS
K930282
Elscint, Inc.
Radiology · 214d
Cleared Feb 26, 1993
CONTOUR MAMMOGRAPHY SYSTEM, MODEL NUMBER M-CTR
K925725
Bennett X-Ray Corp.
Radiology · 105d
Cleared Jan 15, 1993
GIOTTO PATIENT BED
K925212
Gold Coast Imaging, Inc.
Radiology · 91d
Cleared Nov 24, 1992
PLANMED CYTOGUIDE
K923471
Planmed OY
Radiology · 133d
Cleared Nov 23, 1992
LORAD DIGITAL SPOT MAMMOGRAPHY
K921962
Lorad Medical Systems, Inc.
Radiology · 210d
Cleared Oct 16, 1992
PATIENT INFORMATION MANAGER (PIM)
K921986
Continental X-Ray Corp.
Radiology · 171d
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 26, 1992
MEYER FOREIGN BODY LOCATOR
K920470
Seymour W. Meyer
Radiology · 211d
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 Jul 01, 1992
DIGITIZER, MODEL # 3-000A-1518
K922619
Lorad Medical Systems, Inc.
Radiology · 33d
Cleared Jun 17, 1992
VJW2919 PNEUMATIC COMPRESSION UPGRADE
K920938
Varian Canada, Inc.
Radiology · 111d
Cleared Feb 04, 1992
AVIVA MAMMOGRAPHIC X-RAY SYSTEM
K915748
Elscint, Inc.
Radiology · 43d
Cleared Feb 03, 1992
MAMMOGRAPHIC X-RAY SYSTEM
K913732
Lorad Medical Systems, Inc.
Radiology · 167d
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