iBreastExam— 510(k) K142926

Substantially Equivalent

Ue Lifesciences, Inc.

FDA 510(k) clearance K142926 for iBreastExam, Substantially Equivalent on 2015-04-23. 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: 2014-10-08
Decision date: 2015-04-23
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Philadelphia, PA, US

Download summary PDF View on FDA.gov ↗

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