IZH · Class II · 21 CFR 892.1710

FDA Product Code IZH: System, X-ray, Mammographic

Leading manufacturers include Elscint, Inc., Fischer Imaging Corp. and Siemens Medical Solutions USA, Inc..

176
Total
176
Cleared
114d
Avg days
1977
Since

FDA 510(k) Cleared System, X-ray, Mammographic Devices (Product Code IZH)

176 devices
1–24 of 176
Cleared Jul 14, 2021
SMART FINDER
K203509
Ims Giotto S.P.A.
Radiology · 226d
Cleared Oct 05, 2020
Affirm Contrast Biopsy
K202294
Hologic, Inc.
Radiology · 53d
Cleared Jul 03, 2019
Biopsy Positioner
K191495
Fujifilm Corporation
Radiology · 28d
Cleared Apr 01, 2016
Affirm Prone Biopsy System
K153486
Hologic, Inc.
Radiology · 119d
Cleared Jan 07, 2011
AFFIRM BREAST BIOPSY GUIDANCE SYSTEM
K103512
Hologic, Inc.
Radiology · 38d
Cleared Apr 06, 2010
DIGITAL SPOT MAMMOGRAPHY SYSTEM
K100692
Hologic, Inc.
Radiology · 27d
Cleared Oct 29, 2004
MAMMOTEST
K042095
Fischer Imaging Corp.
Radiology · 87d
Cleared Apr 23, 2004
LORAD DIGITAL SPOT MAMMOGRAPHY SYSTEM
K040884
Hologic, Inc.
Radiology · 18d
Cleared Apr 19, 2004
SENOGRAPHIC STEREO
K040125
Ge Medical Systems, Inc.
Radiology · 90d
Cleared Feb 02, 2001
OPDIMA
K003945
Siemens Medical Solutions USA, Inc.
Radiology · 43d
Cleared Dec 11, 1998
ADVANCED AUTOMATIC DETECTOR SELECTION OPTION FOR GLORY
K983313
Elscint, Inc.
Radiology · 81d
Cleared Nov 10, 1997
MAMMOTEST ADAPTER DRIVER
K973400
Fischer Imaging Corp.
Radiology · 62d
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 Apr 29, 1996
MAM-CH22S WITH AUTOMATIC FILTER SELECTION OPTION
K960381
Elscint, Inc.
Radiology · 94d
Cleared Jan 26, 1996
SENOGRAPHE PEARL AND SENOGRAPHE SAPPHIRE
K953250
GE Medical Systems
Radiology · 198d
Cleared May 11, 1995
REAL TIME STEREOTIX
K941191
GE Medical Systems
Radiology · 423d
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 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 Sep 20, 1993
CHENOWETH-FRANK RADIOPATHOLOGICAL GRID
K933754
Cook, Inc.
Radiology · 48d

About Product Code IZH - Regulatory Context