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
49–72 of 176
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
Cleared Jan 26, 1996
SENOGRAPHE PEARL AND SENOGRAPHE SAPPHIRE
K953250
GE Medical Systems
Radiology · 198d
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
PREFERENCE MAMMOGRAPHY SYSTEM
K945743
Philips Medical Systems (Cleveland), Inc.
Radiology · 128d
Cleared Mar 23, 1995
ATHENA HFX
K945619
Fischer Imaging Corp.
Radiology · 128d
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 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 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 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 Nov 24, 1992
PLANMED CYTOGUIDE
K923471
Planmed OY
Radiology · 133d
Cleared Oct 16, 1992
PATIENT INFORMATION MANAGER (PIM)
K921986
Continental X-Ray Corp.
Radiology · 171d