PMA P080018

Device: KODAK DIRECTVIEW CR MAMMOGRAPHY FEATURE
Applicant: Carestream Health, Inc.
PMA number: P080018
Supplement: S001
Product code: MUE
Decision date: 2010-12-01
Generic name: Full field digital, system, x-ray, mammographic
Approval order statement: APPROVAL FOR THE KODAK DIRECTVIEW CR MAMMOGRAPHY SYSTEM. THE KODAK DIRECTVIEW CR MAMMOGRAPHY FEATURE TOGETHER WITH KODAK DIRECTVIEW CR MAMMOGRAPHY CASSETTE COMPRISE A DEVICE WHICH WHEN USED IN CONJUNCTION WITH A KODAK DIRECTVIEW CR SYSTEM AND A MAMMOGRAPHIC X-RAY MACHINE, GENERATES DIGITAL MAMMOGRAPHIC IMAGES THAT CAN BE USED FOR SCREENING AND DIAGNOSIS OF BREAST CANCER. IT IS INTENDED FOR USE IN THE SAME CLINICAL APPLICATIONS AS TRADITIONAL SCREEN-FILM BASED MAMMOGRAPHIC SYSTEMS. THE MAMMOGRAPHIC IMAGES CAN BE INTERPRETED BY A QUALIFIED PHYSICIAN USING EITHER HARD COPY FILM OR SOFT COPY DISPLAY AT A WORKSTATION.

Current openFDA PMA Record#

Device: KODAK DIRECTVIEW CR MAMMOGRAPHY FEATURE
Applicant: Carestream Health, Inc.
PMA number: P080018
Supplement: S001
Product code: MUE
Generic name: Full field digital, system, x-ray, mammographic
Decision date: 2010-12-01
Decision code: APPR
Date received: 2010-11-03
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE KODAK DIRECTVIEW CR MAMMOGRAPHY SYSTEM. THE KODAK DIRECTVIEW CR MAMMOGRAPHY FEATURE TOGETHER WITH KODAK DIRECTVIEW CR MAMMOGRAPHY CASSETTE COMPRISE A DEVICE WHICH WHEN USED IN CONJUNCTION WITH A KODAK DIRECTVIEW CR SYSTEM AND A MAMMOGRAPHIC X-RAY MACHINE, GENERATES DIGITAL MAMMOGRAPHIC IMAGES THAT CAN BE USED FOR SCREENING AND DIAGNOSIS OF BREAST CANCER. IT IS INTENDED FOR USE IN THE SAME CLINICAL APPLICATIONS AS TRADITIONAL SCREEN-FILM BASED MAMMOGRAPHIC SYSTEMS. THE MAMMOGRAPHIC IMAGES CAN BE INTERPRETED BY A QUALIFIED PHYSICIAN USING EITHER HARD COPY FILM OR SOFT COPY DISPLAY AT A WORKSTATION.