FDA 510(k)

FirstSense Breast Exam

K-Number: K160573 · 2016-06-01

Decision Date2016-06-01

Product CodeLHQ

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

FirstSense Breast Exam is the device name listed in this FDA 510(k) record. The listed applicant is First Sense Medical, LLC. It received FDA 510(k) clearance on 2016-06-01 under 510(k) number K160573. 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 FirstSense Breast Exam?

FirstSense Breast Exam is a medical device that received FDA 510(k) clearance on 2016-06-01. The listed applicant is First Sense Medical, LLC. The 510(k) number is K160573.

When did FirstSense Breast Exam receive FDA 510(k) clearance?

FirstSense Breast Exam received FDA 510(k) clearance on 2016-06-01, under 510(k) number K160573.

Who is the listed applicant for FirstSense Breast Exam?

The FDA 510(k) record lists First Sense Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FirstSense Breast Exam?

The FDA product code for FirstSense Breast Exam is LHQ.

Other records listing First Sense Medical, LLC 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.

K162767Sentinel BreastScan II System

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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.