PMA P970058S025
- Device
- IMAGECHECKER CAD
- Applicant
- Hologic, Inc.
- PMA number
- P970058
- Supplement
- S025
- Product code
- MYN
- Decision date
- 2012-09-21
- Generic name
- Analyzer, medical image
- Approval order statement
- APPROVAL FOR IMPROVEMENTS IN THE CAD ALGORITHM, UPDATED DIGITAL TEST DATABASE AND SUPPORT FOR GE SENOGRAPHE ESSENTIAL FFDM.
Current openFDA PMA Record#
- Device
- IMAGECHECKER CAD
- Applicant
- Hologic, Inc.
- PMA number
- P970058
- Supplement
- S025
- Product code
- MYN
- Generic name
- Analyzer, medical image
- Decision date
- 2012-09-21
- Decision code
- APPR
- Date received
- 2012-02-06
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR IMPROVEMENTS IN THE CAD ALGORITHM, UPDATED DIGITAL TEST DATABASE AND SUPPORT FOR GE SENOGRAPHE ESSENTIAL FFDM.