Siemens Mammomat Novationdr Full Field Digital Mammography System

FDA premarket approval P030010 · Full field digital, system, x-ray, mammographic

PMA numberP030010

Approval

Applicant
Siemens Medical Solution
Received
April 10, 2003
Decision date
August 20, 2004 (APRL)
Supplements
6, latest November 5, 2010
Product code
MUE – Full Field Digital, System, X-Ray, Mammographic

Official FDA PMA record

Approval order statement

APPROVAL FOR THE SIEMENS MAMMOMAT NOVATIONDR FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM. THE DEVICE GENERATES DIGITAL MAMMOGRAPHIC IMAGES THAT CAN BE USED FOR SCREENING AND DIAGNOSIS OF BREAST CANCER AND IS INTENDED FOR USE IN THE SAME CLINICAL APPLICATIONS AS TRADITIONAL FILM-BASED MAMMOGRAPHIC SYSTEMS. THESE MAMMOGRAPHIC IMAGES CAN BE INTERPRETED BY EITHER HARDCOPY FILM OR BY SOFTCOPY AT A WORKSTATION.