PMA P000041S010
- Device
- CLEARREAD DETECT
- Applicant
- Riverain Medical Group
- PMA number
- P000041
- Supplement
- S010
- Product code
- MYN
- Decision date
- 2011-11-08
- Generic name
- Analyzer, medical image
- Approval order statement
- APPROVAL FOR THE ONGUARD 5.2.1 COMPUTER AIDED DETECTION SOFTWARE.
Current openFDA PMA Record#
- Device
- CLEARREAD DETECT
- Applicant
- Riverain Medical Group
- PMA number
- P000041
- Supplement
- S010
- Product code
- MYN
- Generic name
- Analyzer, medical image
- Decision date
- 2011-11-08
- Decision code
- APPR
- Date received
- 2011-09-02
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE ONGUARD 5.2.1 COMPUTER AIDED DETECTION SOFTWARE.