Imaging Diagnostic gets Class III classification for breast imaging tool

08/10/2011 | HealthImaging.com

Imaging Diagnostic Systems will have to file a premarket approval application with the FDA after the agency classified its CTLM system, a breast imaging device, as a Class III device. The agency concluded that the company's device "is not substantially equivalent" to devices cleared through the 510(k) process or to systems categorized as Class I or Class II devices.

View Full Article in:

HealthImaging.com

Published in Brief:

SmartBrief Job Listings for Health Care

Job Title Company Location
Manager, Business Conduct
Gilead
Foster City, CA
Product Patent Attorney
Gilead
Foster City, CA
Employment Counsel
Gilead
Foster City, CA
Junior to Mid-Level FDA Associate
Morgan Lewis
Washington, DC
Global Counsel - Advertising and Promotions
Mylan Inc.
Washington, DC