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IZH — System, X-Ray, Mammographic Class II

FDA Device Classification

Classification Details

Product Code
IZH
Device Class
Class II
Regulation Number
892.1710
Submission Type
Review Panel
RA
Medical Specialty
Radiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K203509ims giottoSMART FINDERJuly 14, 2021
K202294hologicAffirm Contrast BiopsyOctober 5, 2020
K191495fujifilm corporationBiopsy PositionerJuly 3, 2019
K161575hologicAffirm Lateral Arm Upright Biopsy AccessoryAugust 10, 2016
K161920precision dynamics corporationComfort CoverJuly 15, 2016
K153486hologicAffirm Prone Biopsy SystemApril 1, 2016
K152038women imaging solutions enterprisesMammoGRIPDecember 22, 2015
K123414macbrud corp., medical divisionSPECBOARD JR.January 11, 2013
K122836lorad, a hologicAFFIRM BREAST BIOPSY GUIDANCE SYSTEMJanuary 11, 2013
K113607giotto usaBIOPSY DIGIT S BIOPSY SLAugust 10, 2012
K113284fuji film medical systemsBIOPSY POSITIONERMarch 7, 2012
K103512hologicAFFIRM BREAST BIOPSY GUIDANCE SYSTEMJanuary 7, 2011
K101373izi medical productsEMBRACESeptember 15, 2010
K100692hologicDIGITAL SPOT MAMMOGRAPHY SYSTEMApril 6, 2010
K073262beekleyBELLAMarch 26, 2008
K071787dja distributorsBEMITT, MODEL 0001October 26, 2007
K071542lorad, a hologicDIGITAL STEREOLOC IIJuly 5, 2007
K070344liv international usaLIV BREAST SELF EXAMINATION AIDMarch 8, 2007
K062039giotto usaBIOPSY DIGIT-AMSeptember 11, 2006
K050663traxyz medicalTRAXYLOC-1 SYSTEMApril 8, 2005