HOLOGIC SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
FDA premarket approval P010025/S009 · decided 2007-01-17
Approval details
- PMA number
- P010025
- Supplement
- S009
- 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
- 2006-11-24
- Decision date
- 2007-01-17
- Days to decision
- 54 days
- Decision code
- APPR
- Product code
- MUE
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Danbury, CT
- Statement
- APPROVAL FOR MOUNTING HOLOGIC SECURVIEW REFERENCE IMAGE VIEWER INTO THE SELENIA ACQUISITION WORKSTATION (AWS) CABINET FOR RETRIEVING AND DISPLAYING PATIENT?S PRIOR IMAGES BUT NOT FOR PRIMARY IMAGE DIAGNOSIS.
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