FDA 510(k) Applications for Medical Device Product Code "NKA"
(System, Documentation, Breast Lesion)

FDA 510(k) Number Applicant Device Name Decision Date
DEN020001 ASSURANCE MEDICAL BREASTVIEW VISUAL MAPPING SYSTEM 01/31/2003
K181672 Sure Inc. SureTouch Mobile Pressure Mapping System 06/28/2019
K190575 UE LifeSciences Inc. iBreastExam 07/16/2019
K142926 UE LIFESCIENCES, INC. iBreastExam 04/23/2015


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