PMA P010038S017
- Device
- SECONDLOOK DIGITAL
- Applicant
- Icad, Inc.
- PMA number
- P010038
- Supplement
- S017
- Product code
- MYN
- Decision date
- 2013-06-19
- Classification
- Analyzer, Medical Image
- Generic name
- Analyzer, medical image
- Approval order statement
- APPROVAL OF SECONDLOOK V7.2 CAD FOR USE WITH THE FUJI ASPIRE HD FULL-FIELD DIGITAL MAMMOGRAPHY (FFDM) SYSTEM
Current openFDA PMA Record#
- Device
- SECONDLOOK DIGITAL
- Applicant
- Icad, Inc.
- PMA number
- P010038
- Supplement
- S017
- Product code
- MYN
- Generic name
- Analyzer, medical image
- Decision date
- 2013-06-19
- Decision code
- APPR
- Date received
- 2012-10-05
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL OF SECONDLOOK V7.2 CAD FOR USE WITH THE FUJI ASPIRE HD FULL-FIELD DIGITAL MAMMOGRAPHY (FFDM) SYSTEM