SENOSCAN FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
FDA premarket approval P010017 · decided 2001-09-25
Approval details
- PMA number
- P010017
- Trade name
- SENOSCAN FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
- Generic name
- Full field digital, system, x-ray, mammographic
- Applicant
- Hologic, Inc.
- Date received
- 2001-03-13
- Decision date
- 2001-09-25
- Days to decision
- 196 days
- Decision code
- APRL
- Product code
- MUE
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Bedford, MA
- Statement
- APPROVAL FOR THE SENOSCAN(R) FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM. THE DEVICE IS A DEDICATED MAMMOGRAPHY SYSTEM INTENDED TO PRODUCE RADIOGRAPHIC IMAGES OF THE HUMAN BREAST FOR THE PURPOSE OF DIAGNOSTIC AND SCREENING MAMMOGRAPHY. THE SENOSCAN(R) FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM IS INTENDED TO BE USED IN THE SAME CLINICAL APPLICATIONS AS TRADITIONAL FILM-BASED MAMMOGRAPHY SYSTEMS.
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