KODAK DIRECTVIEW COMPUTED RADIOGRAPHY (CR) MAMMOGRAPHY
FDA premarket approval P080018 · decided 2010-11-03
Approval details
- PMA number
- P080018
- Trade name
- KODAK DIRECTVIEW COMPUTED RADIOGRAPHY (CR) MAMMOGRAPHY
- Generic name
- Full field digital, system, x-ray, mammographic
- Applicant
- Carestream Health, Inc.
- Date received
- 2008-07-28
- Decision date
- 2010-11-03
- Days to decision
- 828 days
- Decision code
- APRL
- Product code
- MUE
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Rochester, NY
- Statement
- APPROVAL FOR THE KODAK DIRECTVIEW CR MAMMOGRAPHY SYSTEM. THE DEVICE IS INDICATED FOR 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 MAMMOGR
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