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510(k) K190575

Device
IBreastExam
Applicant
UE LifeSciences Inc.
510(k) number
K190575
Product code
NKA  
Decision
Substantially Equivalent (SESE)
Decision date
2019-07-16
Date received
2019-03-06
Regulation
884.2990
Classification name
System, Documentation, Breast Lesion
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Abbreviated
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Mihir Shah
Address
3401 Market St., Suite 200 Philadelphia PA US 19104 19104

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NKA  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K181672SureTouch Mobile Pressure Mapping SystemSure, Inc.2019-06-28
K142926iBreastExamUe Lifesciences, Inc.2015-04-23
DEN020001BREASTVIEW VISUAL MAPPING SYSTEMAssurance Medical2003-01-31

Legacy Summary#

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FDA Review#

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