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

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 Aug 10, 2016
Affirm Lateral Arm Upright Biopsy Accessory
K161575
Hologic
Radiology · 64d
Cleared Jul 15, 2016
Comfort Cover
K161920
Precision Dynamics Corporation
Radiology · 2d
Cleared Apr 01, 2016
Affirm Prone Biopsy System
K153486
Hologic, Inc.
Radiology · 119d
Cleared Dec 22, 2015
MammoGRIP
K152038
Women'S Imaging Solutions Enterprises, LLC
Radiology · 153d
Cleared Jan 11, 2013
AFFIRM BREAST BIOPSY GUIDANCE SYSTEM
K122836
Lorad, A Hologic Co.
Radiology · 116d
Cleared Jan 11, 2013
SPECBOARD JR.
K123414
Macbrud Corp., Medical Division
Radiology · 66d
Cleared Aug 10, 2012
BIOPSY DIGIT S BIOPSY SL
K113607
Giotto USA, LLC
Radiology · 248d
Cleared Mar 07, 2012
BIOPSY POSITIONER
K113284
Fuji Film Medical Systems
Radiology · 121d
Cleared Jan 07, 2011
AFFIRM BREAST BIOPSY GUIDANCE SYSTEM
K103512
Hologic, Inc.
Radiology · 38d
Cleared Sep 15, 2010
EMBRACE
K101373
Izi Medical Products, Inc.
Radiology · 121d
Cleared Apr 06, 2010
DIGITAL SPOT MAMMOGRAPHY SYSTEM
K100692
Hologic, Inc.
Radiology · 27d
Cleared Mar 26, 2008
BELLA
K073262
Beekley Corp.
Radiology · 127d
Cleared Oct 26, 2007
BEMITT, MODEL 0001
K071787
Dja Distributors, LLC
Radiology · 116d
Cleared Jul 05, 2007
DIGITAL STEREOLOC II
K071542
Lorad, A Hologic Co.
Radiology · 30d
Cleared Mar 08, 2007
LIV BREAST SELF EXAMINATION AID
K070344
Liv International USA, Inc.
Radiology · 30d
Cleared Sep 11, 2006
BIOPSY DIGIT-AM
K062039
Giotto USA, LLC
Radiology · 54d
Cleared Apr 08, 2005
TRAXYLOC-1 SYSTEM
K050663
Traxyz Medical, Inc.
Radiology · 24d
Cleared Nov 19, 2004
PLANMED SOPHIE NUANCE CLASSIC
K042671
Planmed OY
Radiology · 51d
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

About Product Code IZH - Regulatory Context