Imaging Diagnostic gets Class III classification for breast imaging tool

08/10/2011 |

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:

Published in Brief:

SmartBrief Job Listings for Health Care

Job Title Company Location
Chief Financial Officer
Health Alliance Plan of Michigan
Southfield, MI
Senior Vice-President Managed Care Mid-Atlantic Region
Mercy Health System
Conshohocken, PA
Associate Chief Financial Officer
Commonwealth Care Alliance
Boston, MA
Assistant General Counsel, Regulatorya
Cardinal Health
Waukegan, IL
Chief Operating Officer
Health Plan of San Joaquin
French Camp , CA