Cleared Traditional

K160573 - FirstSense Breast Exam

K160573 is an FDA 510(k) clearance for FirstSense Breast Exam, manufactured by First Sense Medical, LLC. The device is a Class 1 Radiology device with product code LHQ cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K160573 · First Sense Medical, LLC · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K160573

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 107d · This submission: 93d
Pathway characteristics
Predicate-based equivalence.

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 Consultant

Hogan Lovells US LLP
John J. Smith

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K160573.
InTouch Thermal Camera
K181716 · Intouch Technologies, Inc., D.B.A. Intouch Health · Mar 2019
Med-Hot Thermal Imaging Systems
K171928 · Med-Hot Thermal Imaging, Inc. · Dec 2017
Sentinel BreastScan II System
K162767 · First Sense Medical, LLC · Jan 2017
AlfaSight 9000 Thermographic System
K150457 · Alfa Thermodiagnostics, Inc. · Apr 2015
NOTOUCH BREASTSCAN
K113259 · Ue Lifesciences, Inc. · Feb 2012
AG THERMOGRAPHIC CAMERA, MODEL ATIR-M301
K101641 · Ag Digital Technology Corp. · Jun 2011
K160573 · FirstSense Breast Exam
Download PDF FDA Summary First Sense Medical, …