FDA.report

510(k) K202294

Device
Affirm Contrast Biopsy
Applicant
Hologic, Inc.
510(k) number
K202294
Product code
IZH
Decision
Substantially Equivalent (SESE)
Decision date
2020-10-05
Date received
2020-08-13
Regulation
892.1710
Classification name
System, X-Ray, Mammographic
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Kate Brown
Address
36 Apple Ridge Rd. Danbury CT US 06810 06810

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Other 510(k) Records For Product Code IZH

510(k)DeviceApplicantDecision date
K203509SMART FINDERIms Giotto S.P.A.2021-07-14
K191495Biopsy PositionerFujifilm Corporation2019-07-03
K161575Affirm Lateral Arm Upright Biopsy AccessoryHologic2016-08-10
K161920Comfort CoverPrecision Dynamics Corporation2016-07-15
K153486Affirm Prone Biopsy SystemHologic, Inc.2016-04-01
K152038MammoGRIPWomen'S Imaging Solutions Enterprises, LLC2015-12-22
K123414SPECBOARD JR.Macbrud Corp., Medical Division2013-01-11
K122836AFFIRM BREAST BIOPSY GUIDANCE SYSTEMLorad, A Hologic Co.2013-01-11
K113607BIOPSY DIGIT S BIOPSY SLGiotto USA, LLC2012-08-10
K113284BIOPSY POSITIONERFuji Film Medical Systems2012-03-07
K103512AFFIRM BREAST BIOPSY GUIDANCE SYSTEMHologic, Inc.2011-01-07
K101373EMBRACEIzi Medical Products, Inc.2010-09-15
K100692DIGITAL SPOT MAMMOGRAPHY SYSTEMHologic, Inc.2010-04-06
K073262BELLABeekley Corp.2008-03-26
K071787BEMITT, MODEL 0001Dja Distributors, LLC2007-10-26