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FDA 510(k)

FirstSense Breast Exam

K-Number: K160573 · 2016-06-01

ApplicantFirst Sense Medical, LLC
Decision Date2016-06-01
Product CodeLHQ
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

FirstSense Breast Exam is a medical device manufactured by First Sense Medical, LLC. It received FDA 510(k) clearance on 2016-06-01 under approval 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. It is manufactured by First Sense Medical, LLC. The 510(k) number is K160573.

When was FirstSense Breast Exam approved by the FDA?

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

What company makes FirstSense Breast Exam?

FirstSense Breast Exam is manufactured by First Sense Medical, LLC.

What is the FDA product code for FirstSense Breast Exam?

The FDA product code for FirstSense Breast Exam is LHQ.

Other Devices by First Sense Medical, LLC

K162767Sentinel BreastScan II System

Related Devices (Code: LHQ)

K171928Med-Hot Thermal Imaging SystemsMed-Hot Thermal Imaging, Inc. K162767Sentinel BreastScan II SystemFirst Sense Medical, LLC K181716InTouch Thermal CameraIntouch Technologies, Inc., D.B.A. Intouch Health K212412IRIS-XPMedicore Co., Ltd. K200999Thermidas IR System (ThIR-A615)Thermidas Americas, Inc. K213650ThermPix Thermovisual CameraUsa Therm, Inc.

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.

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