510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K162767Substantially Equivalent

Sentinel BreastScan II System

First Sense Medical, LLC, Pontiac MI / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K162767 is the FDA 510(k) clearance record for Sentinel BreastScan II System, a class I device, cleared for First Sense Medical, LLC on under FDA product code LHQ (System, Telethermographic (Adjunctive Use)). FDA records list 2 510(k) clearances for First Sense Medical, LLC, from to . As of , FDA records show no recalls naming K162767.

Clearance record

Decision date
Received
(101 days to decision)
Product code
LHQ System, Telethermographic (Adjunctive Use)
Regulation
21 CFR 884.2980
Device class
Class I
Review panel
Obstetrics/Gynecology
Applicant
First Sense Medical, LLC 2001 Centerpoint Pkwy.S, Suite 110, Pontiac MI
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LHQ

Trailing 12 months
1 clearance under product code LHQ in the twelve months to October 2026, May 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LHQ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260