MammoGRIP— 510(k) K152038

Substantially Equivalent

Women'S Imaging Solutions Enterprises, LLC

FDA 510(k) clearance K152038 for MammoGRIP, Substantially Equivalent on 2015-12-22. Applicant: Women'S Imaging Solutions Enterprises, LLC.

Clearance details

Applicant
Women'S Imaging Solutions Enterprises, LLC
Product code
Code IZH
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Cresskill, NJ, US
Download summary PDFView on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.