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FDA 510(k)

iBreastExam

K-Number: K190575 · 2019-07-16

ApplicantUe Lifesciences, Inc.
Decision Date2019-07-16
Product CodeNKA
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

iBreastExam is the device name listed in this FDA 510(k) record. The listed applicant is Ue Lifesciences, Inc.. It received FDA 510(k) clearance on 2019-07-16 under 510(k) 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. The listed applicant is Ue Lifesciences, Inc.. The 510(k) number is K190575.

When did iBreastExam receive FDA 510(k) clearance?

iBreastExam received FDA 510(k) clearance on 2019-07-16, under 510(k) number K190575.

Who is the listed applicant for iBreastExam?

The FDA 510(k) record lists Ue Lifesciences, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for iBreastExam?

The FDA product code for iBreastExam is NKA.

Related Devices (Code: NKA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K181672SureTouch Mobile Pressure Mapping SystemSure, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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