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510(k) K010116

Device
PLANMED SOPHIE, PLANMED SOPHIE CLASSIC
Applicant
Planmed OY
510(k) number
K010116
Product code
IZH
Decision
Substantially Equivalent (SESE)
Decision date
2001-03-15
Date received
2001-01-16
Regulation
892.1710
Classification name
System, X-Ray, Mammographic
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
N

Applicant Contact#

Contact
BOB PIENKOWSKI
Address
1250 Greenbriar, Suite A Addison IL US 60101 60101

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code IZH#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K203509SMART FINDERIms Giotto S.P.A.2021-07-14
K202294Affirm Contrast BiopsyHologic, Inc.2020-10-05
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