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
49–72 of 176
Cleared Jul 30, 1999
MAMEX
K992037
Del Medical Imaging Corp.
Radiology · 44d
Cleared Mar 12, 1999
BIOPSY-DIGIT
K990192
Sitco, Inc.
Radiology · 50d
Cleared Feb 05, 1999
CONTOUR 2000 MAMMOGRAPHY SYSTEM, MODEL CTR- 2000
K984091
Trex Medical Corp.
Radiology · 81d
Cleared Feb 05, 1999
PROFILE 2000 MAMMOGRAPHY SYSTEM, PRO-2000
K984092
Trex Medical Corp.
Radiology · 81d
Cleared Dec 11, 1998
ADVANCED AUTOMATIC DETECTOR SELECTION OPTION FOR GLORY
K983313
Elscint, Inc.
Radiology · 81d
Cleared Nov 16, 1998
PLANMED SOPHIE & PLANNED SOPHIE CLASSIC
K983659
Planmed OY
Radiology · 28d
Cleared Nov 03, 1998
NEEDLE GUIDE
K983621
Remington Medical, Inc.
Radiology · 19d
Cleared Jul 17, 1998
MAMMOGRAPHY X-RAY EQUIPMENT MODELS MGF101 AND MGF110, ALPHA III, ALPHA ST, ALPHA RT AND ALPHA IQ
K981641
Instrumentarium Corp.
Radiology · 70d
Cleared Jul 14, 1998
BIOPSY M
K982049
Sitco, Inc.
Radiology · 33d
Cleared Jun 19, 1998
WORLDWIDE MEDICAL TECHNOLOGIES NEEDLE GUIDE
K981470
Worldwide Medical Technologies, LLC
Radiology · 57d
Cleared Apr 09, 1998
REMOTE HAND CONTROL TO THE INFLATABLE POSITIONING CUSHION (A.K.A. IMAGEAIR)
K980235
Kci New Technologies, Inc.
Radiology · 77d
Cleared Dec 23, 1997
LORAD M-III ELITE (M-III E)
K973631
Lorad Corp.
Radiology · 90d
Cleared Nov 21, 1997
GIOTTO HT
K973856
Sitco, Inc.
Radiology · 43d
Cleared Nov 10, 1997
MAMMOTEST ADAPTER DRIVER
K973400
Fischer Imaging Corp.
Radiology · 62d
Cleared Nov 10, 1997
PLANMED CYTOGUIDE
K973493
Planmed OY
Radiology · 56d
Cleared Nov 10, 1997
INFLATABLE POSITIONING CUSHIONS
K973915
Kci New Technologies, Inc.
Radiology · 27d
Cleared Jun 20, 1997
GLORY
K970680
Elscint, Inc.
Radiology · 116d
Cleared May 08, 1997
DSBAS OPTION THE MAMMOMAT 3000 MAMMOGRAPHY X-RAY SYSTEM
K964069
Siemens Medical Solutions USA, Inc.
Radiology · 210d
Cleared Mar 19, 1997
GIOTTO HIGH TECH (H.T.) MAMMOGRAPHIC SYSTEM
K953902
Medical Marketing Intl., Inc.
Radiology · 579d
Cleared Feb 05, 1997
PLANNED SOPHIED CLASSIC
K962105
Planmed OY
Radiology · 250d
Cleared Jan 10, 1997
PROFILE MAMMOGRAPHY SYSTEM (M-PRO)
K964576
Bennett X-Ray Corp.
Radiology · 57d
Cleared Aug 21, 1996
THE ROBOGUIDE
K961849
Shai Syg Motion and Innovations, Ltd.
Radiology · 100d
Cleared Apr 29, 1996
MAM-CH22S WITH AUTOMATIC FILTER SELECTION OPTION
K960381
Elscint, Inc.
Radiology · 94d
Cleared Mar 21, 1996
DELTA 16
K955411
Instrumentarium Imaging, Inc.
Radiology · 115d