NKA

System, Documentation, Breast Lesion

Product code

NKA

Device name

System, Documentation, Breast Lesion

Device class

Class 2

21 CFR

21 CFR 884.2990

Medical specialty

Obstetrics/Gynecology

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

4 (all years; only the last 3 years are listed here)

FDA classification definition

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

Definition text from the FDA device classification database (U.S. federal government work, public domain).