HOLOGIC SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
FDA premarket approval P010025/S010 · decided 2007-06-01
Approval details
- PMA number
- P010025
- Supplement
- S010
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- HOLOGIC SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
- Generic name
- Full field digital, system, x-ray, mammographic
- Applicant
- Hologic, Inc.
- Date received
- 2007-03-12
- Decision date
- 2007-06-01
- Days to decision
- 81 days
- Decision code
- APPR
- Product code
- MUE
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Danbury, CT
- Statement
- APPROVAL FOR A CHANGE TO THE BLEMISHED PIXEL SPECIFICATIONS.
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