Medical Device Manufacturer · US , Cresskill , NJ

Women'S Imaging Solutions Enterprises, LLC - FDA 510(k) Cleared Devic...

1 submissions · 1 cleared · Since 2015

Recent clearances: MammoGRIP

View 1 510(k) Devices ↓

1

Total

1

Cleared

0

Denied

FDA 510(k) Regulatory Record - Women'S Imaging Solutions Enterprises, LLC Radiology ✕

1 devices

1-1 of 1

Cleared Dec 22, 2015

Radiology · 153d

Data Source

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

Last updated: Sep 22, 2026