PMA P010038S004
- Device
- ICAD SYSTEM
- Applicant
- Icad, Inc.
- PMA number
- P010038
- Supplement
- S004
- Product code
- MYN
- Decision date
- 2003-10-10
- Generic name
- Analyzer, medical image
- Approval order statement
- APPROVAL FOR A CHANGE IN THE MAMMOGRAPHY FILM DIGITIZER FROM THE FORMERLY APPROVED MULTIRAD 860 TO THE FULCRUM.
Current openFDA PMA Record#
- Device
- ICAD SYSTEM
- Applicant
- Icad, Inc.
- PMA number
- P010038
- Supplement
- S004
- Product code
- MYN
- Generic name
- Analyzer, medical image
- Decision date
- 2003-10-10
- Decision code
- APPR
- Date received
- 2003-06-18
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A CHANGE IN THE MAMMOGRAPHY FILM DIGITIZER FROM THE FORMERLY APPROVED MULTIRAD 860 TO THE FULCRUM.