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FDA 510(k)

Sentinel BreastScan II System

K-Number: K162767 · 2017-01-09

ApplicantFirst Sense Medical, LLC
Decision Date2017-01-09
Product CodeLHQ
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Sentinel BreastScan II System 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 2017-01-09 under 510(k) number K162767. 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 Sentinel BreastScan II System?

Sentinel BreastScan II System is a medical device that received FDA 510(k) clearance on 2017-01-09. The listed applicant is First Sense Medical, LLC. The 510(k) number is K162767.

When did Sentinel BreastScan II System receive FDA 510(k) clearance?

Sentinel BreastScan II System received FDA 510(k) clearance on 2017-01-09, under 510(k) number K162767.

Who is the listed applicant for Sentinel BreastScan II System?

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 Sentinel BreastScan II System?

The FDA product code for Sentinel BreastScan II System 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.

K160573FirstSense Breast Exam

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.

K253911Derma-2Neko Health ABK232462ThermPix Thermovisual CameraUsa Therm, Inc.K213650ThermPix Thermovisual CameraUsa Therm, Inc.K212965Smile-100 SystemNiramai Health Analytix Private LimitedK212412IRIS-XPMedicore Co., Ltd.K200999Thermidas IR System (ThIR-A615)Thermidas Americas, 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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