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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Telethermographic (Adjunctive Use)
510(k) Number K162767
Device Name Sentinel BreastScan II System
Applicant
First Sense Medical, LLC
2001 Centerpoint Pkwy.S, Suite 110
Pontiac,  MI  48341
Applicant Contact Alan Alan Klevens
Correspondent
Hogan Lovells US LLP
555 13th St., NW
Washington,  DC  20004
Correspondent Contact John J. Smith
Regulation Number884.2980
Classification Product Code
LHQ  
Date Received09/30/2016
Decision Date 01/09/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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