iBreastExam
K-Number: K190575 · 2019-07-16
ApplicantUe Lifesciences, Inc.
Decision Date2019-07-16
Product CodeNKA
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
iBreastExam is a medical device manufactured by Ue Lifesciences, Inc.. It received FDA 510(k) clearance on 2019-07-16 under approval number K190575. The device is classified under product code NKA. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the iBreastExam?
iBreastExam is a medical device that received FDA 510(k) clearance on 2019-07-16. It is manufactured by Ue Lifesciences, Inc.. The 510(k) number is K190575.
When was iBreastExam approved by the FDA?
iBreastExam received FDA 510(k) clearance on 2019-07-16, under approval number K190575.
What company makes iBreastExam?
iBreastExam is manufactured by Ue Lifesciences, Inc..
What is the FDA product code for iBreastExam?
The FDA product code for iBreastExam is NKA.
Related Devices (Code: NKA)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.