Medical Device Manufacturer · US , Pontiac , MI

First Sense Medical, LLC - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2016

Recent clearances: Sentinel BreastScan II System, FirstSense Breast Exam

View 2 510(k) Devices ↓

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - First Sense Medical, LLC Radiology ✕

2 devices

1-2 of 2

Cleared Jan 09, 2017

Sentinel BreastScan II System

Radiology · 101d

Cleared Jun 01, 2016

FirstSense Breast Exam

Radiology · 93d

Data Source

Sourced from the FDA 510(k) public files . 176,325 total devices indexed.

Last updated: Sep 23, 2026