FISCHER IMAGING CORPORATION SENOSCAN FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
FDA premarket approval P010017/S007 · decided 2006-02-13
Approval details
- PMA number
- P010017
- Supplement
- S007
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- FISCHER IMAGING CORPORATION SENOSCAN FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
- Generic name
- Full field digital, system, x-ray, mammographic
- Applicant
- Hologic, Inc.
- Date received
- 2006-01-20
- Decision date
- 2006-02-13
- Days to decision
- 24 days
- Decision code
- APPR
- Product code
- MUE
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Bedford, MA
- Statement
- APPROVAL FOR SOFTWARE CHANGES TO CORRECT SEVERAL "BUGS" THAT IMPROVE SERVICE WORKFLOW EFFICIENCY, IMPROVE USER WORKFLOW EFFICIENCY, AND IMPROVE IMAGE ARCHIVING.
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