Full Field Digital, System, X-Ray, Mammographic
Basic Information
- Device Name
- Full Field Digital, System, X-Ray, Mammographic
- Trade Name
- SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
- PMA Number
- P010025
- Supplement Number
- S001
- Device Class
- FDA Class 2
- Product Code
- MUE
- Generic Name
- Full field digital, system, x-ray, mammographic
- Regulation Number
- 892.1715
- Medical Specialty
- Radiology
- Advisory Committee
- Radiology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- October 2, 2002
- Date Received
- March 29, 2002
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee 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 IN THE SAME CLINICAL APPLICATIONS AS TRADITIONAL SCREEN-FILM MAMMOGRAPHIC SYSTEMS. MAMMOGRAPHIC IMAGES CAN BE INTERPRETED ON EITHER HARD COPY FILM OR THE SELENIA SOFT COPY REVIEW WORKSTATION. ALSO, APPROVAL FOR THE ADDITION OF THE LORAD FACILITY, DANBURY, CONNECTICUT, AS A MANUFACTURING SITE FOR THE SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MUE | Full Field Digital, System, X-Ray, Mammographic | FDA class 2 | Radiology |