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510(k) K142926

iBreastExam by Ue Lifesciences, Inc. — Product Code NKA

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: April 23, 2015
Date Received: October 8, 2014
Clearance Type: Abbreviated
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: System, Documentation, Breast Lesion
Device Class: Class II
Regulation Number: 884.2990
Review Panel: OB
Submission Type

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