Cleared Traditional

K160573 - FirstSense Breast Exam (FDA 510(k) Clearance)

Class I Radiology device.

K160573 · First Sense Medical, LLC · Radiology device
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Jun 2016
Decision
93d
Days
Class 1
Risk

K160573 is an FDA 510(k) clearance for the FirstSense Breast Exam. 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 June 1, 2016 after a review of 93 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all First Sense Medical, LLC devices

Submission Details

510(k) Number K160573 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 29, 2016
Decision Date June 01, 2016
Days to Decision 93 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 107d · This submission: 93d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.