SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
FDA premarket approval P010025/S001 · decided 2002-10-02
Approval details
- PMA number
- P010025
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
- Generic name
- Full field digital, system, x-ray, mammographic
- Applicant
- Hologic, Inc.
- Date received
- 2002-03-29
- Decision date
- 2002-10-02
- Days to decision
- 187 days
- Decision code
- APPR
- Product code
- MUE
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Danbury, CT
- Statement
- APPROVAL FOR AN AMORPHOUS SELENIUM DIGITAL RECEPTOR, A CHANGE IN THE NAME OF THE PRODUCT TO SELENIA AND THE ADDITION OF A SOFT COPY DISPLAY FOR INTERPRETATION OF SCREENING AND DIAGNOSTIC MAMMOGRAMS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM AND IS INDICATED FOR GENERATING DIGITAL MAMMOGRAPHIC IMAGES THAT CAN BE USED FOR SCREENING AND DIAGNOSIS OF BREAST CANCER. THE SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM IS INTENDED FOR USE
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