iBreastExam— 510(k) K190575

Substantially Equivalent

Ue Lifesciences, Inc.

FDA 510(k) clearance K190575 for iBreastExam, Substantially Equivalent on 2019-07-16. Applicant: Ue Lifesciences, Inc.. Device class: 2.

Clearance details

Applicant: Ue Lifesciences, Inc.
Product code: Code NKA
Device class: Class 2
Regulation: 21 CFR 884.2990
Advisory panel: Obstetrics/Gynecology
Date received: 2019-03-06
Decision date: 2019-07-16
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Philadelphia, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code NKA

K181672 — SureTouch Mobile Pressure Mapping System2019-06-28
K142926 — iBreastExam2015-04-23
DEN020001 — BREASTVIEW VISUAL MAPPING SYSTEM2003-01-31

More clearances from Ue Lifesciences, Inc.

K113259 — NOTOUCH BREASTSCAN2012-02-10

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