PMA P100007
- Device
- BREAST COMPANION SOFTWARE SYSTEM
- Applicant
- Almen Laboratories, Inc.
- PMA number
- P100007
- Product code
- MYN
- Decision date
- 2012-02-10
- Generic name
- Analyzer, medical image
- Approval order statement
- APPROVAL FOR THE BREAST COMPANION SOFTWARE SYSTEM. THE BREAST COMPANION IS A COMPUTER-AIDED SYSTEM INTENDED FOR IMPROVING THE ACR BI-RADS ASSESSMENT OF ULTRASOUND IMAGES OF LESIONS OF THE FEMALE BREAST AS PART OF THE DIAGNOSTIC WORKSHOP.
- Summary
- <a href="http://www.accessdata.fda.gov/cdrh_docs/pdf10/P100007B.pdf" target="_new">Summary of Safety and Effectiveness</a>
Current openFDA PMA Record#
- Device
- BREAST COMPANION SOFTWARE SYSTEM
- Applicant
- Almen Laboratories, Inc.
- PMA number
- P100007
- Product code
- MYN
- Generic name
- Analyzer, medical image
- Decision date
- 2012-02-10
- Decision code
- APWD
- Date received
- 2010-02-17
- Approval order statement
- APPROVAL FOR THE BREAST COMPANION SOFTWARE SYSTEM. THE BREAST COMPANION IS A COMPUTER-AIDED SYSTEM INTENDED FOR IMPROVING THE ACR BI-RADS ASSESSMENT OF ULTRASOUND IMAGES OF LESIONS OF THE FEMALE BREAST AS PART OF THE DIAGNOSTIC WORKSHOP.