NKA · Class II · 21 CFR 884.2990

FDA Product Code NKA: System, Documentation, Breast Lesion

A Breast Lesion Documentation Device Is A Device For Recording And Documenting Palpable Breast Lesions Detected During A Clinical Breast Exam.

Leading manufacturers include Sure, Inc. and Ue Lifesciences, Inc..

4
Total
3
Cleared
236d
Avg days
2003
Since

FDA 510(k) Cleared System, Documentation, Breast Lesion Devices (Product Code NKA)

4 devices
1–4 of 4
Cleared Jul 16, 2019
iBreastExam
K190575
Ue Lifesciences, Inc.
Obstetrics & Gynecology · 132d
Cleared Jun 28, 2019
SureTouch Mobile Pressure Mapping System
K181672
Sure, Inc.
Obstetrics & Gynecology · 368d

About Product Code NKA - Regulatory Context