DeviceClearance

Product code NKA— Obstetrics/Gynecology

iBreastExam

Classification name
System, Documentation, Breast Lesion
Device class
Class 2
Regulation
21 CFR 884.2990
Advisory panel
Obstetrics/Gynecology
Total cleared
4
First cleared
Most recent

FDA classification definition

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

— U.S. Food and Drug Administration, device classification record for product code NKA under 21 CFR 884.2990, via openFDA

Market context for product code NKA

FDA has cleared 4 devices under product code NKA between 2003 and 2019, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code NKA

Recent clearances under product code NKA

Data sourced from openFDA. This site is unofficial and independent of the FDA.