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510(k) K981641

Device
MAMMOGRAPHY X-RAY EQUIPMENT MODELS MGF101 AND MGF110, ALPHA III, ALPHA ST, ALPHA RT AND ALPHA IQ
Applicant
INSTRUMENTARIUM CORP.
510(k) number
K981641
Product code
IZH  
Decision
Substantially Equivalent (SESE)
Decision date
1998-07-17
Date received
1998-05-08
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
No

Applicant Contact#

Contact
MAX LINDERT
Address
300 W. Edgerton Ave. Milwaukee WI US 53207 53207

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

Legacy Summary#

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FDA Review#

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