PMA P100005S002
- Device
- M-VU ALGORITHM ENGINE
- Applicant
- Icad, Inc.
- PMA number
- P100005
- Supplement
- S002
- Product code
- MYN
- Decision date
- 2013-06-19
- Generic name
- Analyzer, medical image
- Approval order statement
- APPROVAL OF M-VU ALGORITHM ENGINE VERSION 2.1.2.0 FOR USE WITH THE FUJIFCRM COMPUTED RADIOGRAPHY (CR) FULL-FIELD DIGITAL MAMMOGRAPHY (FFDM) SYSTEM.
Current openFDA PMA Record#
- Device
- M-VU ALGORITHM ENGINE
- Applicant
- Icad, Inc.
- PMA number
- P100005
- Supplement
- S002
- Product code
- MYN
- Generic name
- Analyzer, medical image
- Decision date
- 2013-06-19
- Decision code
- APPR
- Date received
- 2013-03-21
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL OF M-VU ALGORITHM ENGINE VERSION 2.1.2.0 FOR USE WITH THE FUJIFCRM COMPUTED RADIOGRAPHY (CR) FULL-FIELD DIGITAL MAMMOGRAPHY (FFDM) SYSTEM.