Cleared Special

K162767 - Sentinel BreastScan II System

K162767 is an FDA 510(k) clearance for Sentinel BreastScan II System, manufactured by First Sense Medical, LLC. The device is a Class 1 Radiology device with product code LHQ cleared through the Special 510(k) pathway after a 101-day FDA review.

K162767 · First Sense Medical, LLC · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2017
Decision
101d
Days
Class 1
Risk

K162767 is an FDA 510(k) clearance for the Sentinel BreastScan II System. Classified as System, Telethermographic (adjunctive Use) (product code LHQ), Class I - General Controls.

Submitted by First Sense Medical, LLC (Pontiac, US). The FDA issued a Cleared decision on January 9, 2017 after a review of 101 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 884.2980 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K162767

510(k) Number K162767 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2016
Decision Date January 09, 2017
Days to Decision 101 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 107d · This submission: 101d
Pathway characteristics
Modification to existing cleared device.

LHQ Device Classification - Class 1, General Controls

Product Code LHQ System, Telethermographic (adjunctive Use)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 884.2980
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - LHQ System, Telethermographic (adjunctive Use)

All 33
Devices cleared under the same product code (LHQ) and FDA review panel - the closest regulatory comparables to K162767.
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Med-Hot Thermal Imaging Systems
K171928 · Med-Hot Thermal Imaging, Inc. · Dec 2017
FirstSense Breast Exam
K160573 · First Sense Medical, LLC · Jun 2016
AlfaSight 9000 Thermographic System
K150457 · Alfa Thermodiagnostics, Inc. · Apr 2015
NOTOUCH BREASTSCAN
K113259 · Ue Lifesciences, Inc. · Feb 2012
K162767 · Sentinel BreastScan II System
Download PDF FDA Summary First Sense Medical, …