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
73–96 of 176
Cleared Jan 26, 1996
SENOGRAPHE PEARL AND SENOGRAPHE SAPPHIRE
K953250
GE Medical Systems
Radiology · 198d
Cleared Dec 22, 1995
SENSOR PAD
K955249
Inventive Products, Inc.
Radiology · 37d
Cleared Oct 24, 1995
MAMMOSPOT PADDLE
K954521
American Mammographics, Inc.
Radiology · 26d
Cleared Jul 24, 1995
LORAD STEROLOC II
K952210
Lorad Corp.
Radiology · 75d
Cleared May 24, 1995
PLANMED SOPHIE MAMMOGRAPHIC X-RAY UNIT
K951883
Planmed OY
Radiology · 51d
Cleared May 11, 1995
REAL TIME STEREOTIX
K941191
GE Medical Systems
Radiology · 423d
Cleared May 03, 1995
BENNETT X-RAY DIGITAL SPOT IMAGING SYSTEM MODEL M-DSI
K944978
Bennett X-Ray Corp.
Radiology · 204d
Cleared Apr 03, 1995
BENNETT X-RAY PROFILE POSITIONING PADDLE FOR MAMMOGRAPHY
K945962
Bennett X-Ray Corp.
Radiology · 117d
Cleared Mar 31, 1995
MAM-CH22S MAMMOGRAPHY SYSTEM WITH OPTIONAL MAMMOGUIDE STERIOTACTIC BIOPSY SYSTEM
K941353
Elscint, Inc.
Radiology · 375d
Cleared Mar 31, 1995
LORAD M-IV, LORAD M-IVI
K945241
Lorad Corp.
Radiology · 155d
Cleared Mar 31, 1995
PREFERENCE MAMMOGRAPHY SYSTEM
K945743
Philips Medical Systems (Cleveland), Inc.
Radiology · 128d
Cleared Mar 23, 1995
ATHENA HFX
K945619
Fischer Imaging Corp.
Radiology · 128d
Cleared Mar 02, 1995
DIGITAL SPOT MAMMOGRAPHY FOR STEROTACTIC APPLICATION
K950608
Lorad Corp.
Radiology · 21d
Cleared Feb 08, 1995
NOVA XM2
K932356
Dynarad Corp.
Radiology · 636d
Cleared Feb 08, 1995
SUREVIEW MQSA OPTION KITS (MODEL NO.'S 377095 & 377096)
K944816
Philips Medical Systems (Cleveland), Inc.
Radiology · 132d
Cleared Jan 31, 1995
ALPHA STEREO
K934478
Instrumentarium Corp.
Radiology · 504d
Cleared Dec 27, 1994
MAMMOGRAPHIC X-RAY UNIT
K945496
Lorad Corp.
Radiology · 49d
Cleared Dec 14, 1994
RHODIUM FILTER
K945272
Lorad Corp.
Radiology · 47d
Cleared Nov 01, 1994
BENNETT X-RAY DIGITAL SPOT IMAGER
K935428
Bennett X-Ray Technologies
Radiology · 356d
Cleared Oct 14, 1994
LORAD TRANSPO
K934868
Lorad Corp.
Radiology · 367d
Cleared Sep 22, 1994
CYTOGUIDE STEREOTATIC BIOPSY SYSTEM
K933430
Gold Coast Imaging, Inc.
Radiology · 436d
Cleared Sep 14, 1994
MAMMOMAT 300 AND MAMMOMAT 3000
K932672
Siemens Medical Solutions USA, Inc.
Radiology · 469d
Cleared Aug 23, 1994
ADVANCED AUTOMATIC KV
K934831
Elscint, Inc.
Radiology · 319d
Cleared May 17, 1994
MAMOSPAT
K935608
E.V.S. Tool & Die Co., Inc.
Radiology · 179d