SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
FDA premarket approval P010025/S002 · decided 2003-09-24
Approval details
- PMA number
- P010025
- Supplement
- S002
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
- Generic name
- Full field digital, system, x-ray, mammographic
- Applicant
- Hologic, Inc.
- Date received
- 2003-03-28
- Decision date
- 2003-09-24
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- MUE
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Danbury, CT
- Statement
- APPROVAL FOR THE FOLLOWING CHANGES IN THE SELENIA QC MANUAL: 1) CHANGE THE MINIMUM SCORES FOR THE ACR PHANTOM TEST TO 5 FIBERS, 4 SPECS, AND 4 MASSES FORM 4 FIBERS, 4 SPECS, AND 3 MASSES. 2) CHANGE THE SIGNAL-TO-NOISE TEST RESULT MINIMUM FROM 40 TO 35. THE 40 VALUE WAS BASED ON THE USE OF THE BR-12 PHANTOM, WHEREAS THE STANDARD PHANTOM IS THE ACT WITH A MINIMUM VALUE OF 35. 3) ADD A SPECIFICATION OF 28 K VP AND 65 MAS FOR PERFORMANCE OF QC TESTING.
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