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FDA 510(k)

NOTOUCH BREASTSCAN

K-Number: K113259 · 2012-02-10

ApplicantUe Lifesciences, Inc.
Decision Date2012-02-10
Product CodeLHQ
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

NOTOUCH BREASTSCAN 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 2012-02-10 under 510(k) number K113259. The device is classified under product code LHQ. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NOTOUCH BREASTSCAN?

NOTOUCH BREASTSCAN is a medical device that received FDA 510(k) clearance on 2012-02-10. The listed applicant is Ue Lifesciences, Inc.. The 510(k) number is K113259.

When did NOTOUCH BREASTSCAN receive FDA 510(k) clearance?

NOTOUCH BREASTSCAN received FDA 510(k) clearance on 2012-02-10, under 510(k) number K113259.

Who is the listed applicant for NOTOUCH BREASTSCAN?

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 NOTOUCH BREASTSCAN?

The FDA product code for NOTOUCH BREASTSCAN is LHQ.

Related Clinical Trials

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.

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Other records listing Ue Lifesciences, Inc. as applicant

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.

K190575iBreastExam

Related Devices (Code: LHQ)

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.

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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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