LORAD DIGITAL BREAST IMAGER
FDA premarket approval P010025 · decided 2002-03-15
Approval details
- PMA number
- P010025
- Trade name
- LORAD DIGITAL BREAST IMAGER
- Generic name
- Full field digital, system, x-ray, mammographic
- Applicant
- Hologic, Inc.
- Date received
- 2001-04-30
- Decision date
- 2002-03-15
- Days to decision
- 319 days
- Decision code
- APRL
- Product code
- MUE
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Danbury, CT
- Statement
- APPROVAL FOR THE LORAD DIGITAL BREAST IMAGER. THE DEVICE 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 MAMMOGRAPHIC SYSTEMS.
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