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
25–48 of 176
Cleared Dec 03, 2003
ADVANTAGE PADDLE
K033202
Livingston Products, Inc.
Radiology · 62d
Cleared Aug 04, 2003
SQUEEZE-EASE MAMMOGRAPHY CUSHION
K031574
S & S X-Ray Products, Inc.
Radiology · 76d
Cleared Mar 25, 2003
MULTICARE PLATINUM SYSTEM AND ACCESSORIES
K030666
Lorad, A Hologic Co.
Radiology · 22d
Cleared Feb 21, 2003
PLANMED SOPHIE & SOPHIE CLASSIC (WITH DIGISPOT AND CYTOGUIDE)
K021945
Planmed OY
Radiology · 253d
Cleared Jan 09, 2003
PERFORMA STEREO
K023864
Instrumentarium Corp. Imaging Division
Radiology · 50d
Cleared Dec 13, 2002
S.O.F.T. PADDLE (SPECIAL OPTIMIZED FULL COMPRESSION TRAY), MODEL SFT-PDLE
K023229
American Mammographics, Inc.
Radiology · 77d
Cleared Sep 12, 2002
BREAST BOLSTER
K020624
Beekley Corp.
Radiology · 198d
Cleared Sep 12, 2002
DELTA 32
K022275
Instrumentarium Corp. Imaging Division
Radiology · 59d
Cleared Jan 16, 2002
PLANMED SOPHIE & PLANMED SOPHIE CLASSIC
K013656
Planmed OY
Radiology · 71d
Cleared Nov 30, 2001
GIOTTO IMAGE
K012953
Medx, Inc.
Radiology · 87d
Cleared Oct 24, 2001
MODIFIED 650 MAMMOGRAPHY SYSTEM
K013290
Lorad, A Hologic Co.
Radiology · 22d
Cleared Jul 11, 2001
MODIFIED M-IV MAMMOGRAPHY SYSTEM
K011987
Lorad, A Hologic Co.
Radiology · 15d
Cleared Apr 03, 2001
MAMMOGRAPH
K010792
Digitec Medical Service Corp.
Radiology · 18d
Cleared Mar 15, 2001
PLANMED SOPHIE, PLANMED SOPHIE CLASSIC
K010116
Planmed OY
Radiology · 58d
Cleared Feb 14, 2001
BIOLUCENT MAMMOGRAPHY CUSHION
K003795
Biolucent, Inc.
Radiology · 68d
Cleared Feb 02, 2001
OPDIMA
K003945
Siemens Medical Solutions USA, Inc.
Radiology · 43d
Cleared Nov 29, 2000
DELTA 32 AND DELTA 32 TACT
K002472
Instrumentarium Imaging, Inc.
Radiology · 110d
Cleared Nov 28, 2000
DIGIMAM DIGITAL STEREOTACTIC BIOPSY SYSTEM OPTION FOR GLORY MAMMOGRAPHIC SYSTEM
K003473
Elscintec Systems , Ltd.
Radiology · 20d
Cleared Jun 01, 2000
DIAMOND (MAMMOGRAPHIC X-RAY SYSTEM)
K000976
Instrumentarium Imaging, Inc.
Radiology · 66d
Cleared May 12, 2000
DELTA 16 TACT
K001171
Instrumentarium Imaging, Inc.
Radiology · 31d
Cleared Dec 21, 1999
DIGITEC TWO STAGE COMPRESSION KIT
K993681
Digitec Medical Service Corp.
Radiology · 50d
Cleared Nov 26, 1999
MAMEX
K993740
Medical Systems Group
Radiology · 22d
Cleared Sep 03, 1999
LORAD 1-650 (INTERNATIONAL 650)
K992280
Lorad Corp.
Radiology · 58d
Cleared Aug 10, 1999
PLANMED SOPHIE AND SOPHIE CLASSIC
K991826
Planmed OY
Radiology · 74d