IMAGE CHECKER M1000 SYSTEM
FDA premarket approval P970058/S016 · decided 2003-09-10
Approval details
- PMA number
- P970058
- Supplement
- S016
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- IMAGE CHECKER M1000 SYSTEM
- Generic name
- Analyzer, medical image
- Applicant
- Hologic, Inc.
- Date received
- 2003-05-08
- Decision date
- 2003-09-10
- Days to decision
- 125 days
- Decision code
- APPR
- Product code
- MYN
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Bedford, MA
- Statement
- APPROVAL FOR A NEW SOFTWARE RELEASE (V5.0) THAT: 1) PROVIDES THE USER WITH A CHOICE OF TWO OPERATING POINTS (ONE WITH HIGHER SENSITIVITY AND INCREASED FALSE MARKS AND THE OTHER WITH LOWER FALSE MARKS WITH DECREASED SENSITIVITY, CHOSEN AT THE TIME OF DEVICE INSTALLATION) FOR USE WITH FILM/SCREEN IMAGES ONLY; 2) WHEN PACKAGED WITH V3.1A SOFTWARE IN A SINGLE IMAGE CHECKER HOUSING, ALLOWS THE PROCESSING OF BOTH ANALOG AND GE FFDM IMAGES; 3) ALLOWS CAD PROCESSING OF GE FFDM DICOM IMAGES FORMATTED FOR
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