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NKA — System, Documentation, Breast Lesion Class II

FDA Device Classification

Classification Details

Product Code
NKA
Device Class
Class II
Regulation Number
884.2990
Submission Type
Review Panel
OB
Medical Specialty
Obstetrics/Gynecology
Implant
No

Definition

A Breast lesion documentation device is a device for recording and documenting palpable breast lesions detected during a clinical breast exam.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K190575ue lifesciencesiBreastExamJuly 16, 2019
K181672sureSureTouch Mobile Pressure Mapping SystemJune 28, 2019
K142926ue lifesciencesiBreastExamApril 23, 2015
DEN020001assurance medicalBREASTVIEW VISUAL MAPPING SYSTEMJanuary 31, 2003