- Device
- INVENIA ABUS-AUTOMATED BREAST ULTRASOUND SYSTEM
- Applicant
- GE Healthcare
- PMA number
- P110006
- Supplement
- S004
- Product code
- PAA
- Generic name
- Automated breast ultrasound
- Decision date
- 2014-11-24
- Decision code
- APPR
- Date received
- 2014-11-03
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL OF A CHANGE IN THE DEVICE DESIGN TO ACCOMMODATE A NEW DEVICE CONFIGURATION. THE NEW DEVICE CONFIGURATION CONSISTS OF THE FOLLOWING COMPONENTS: INVENIA ABUS SCAN STATION, INVENIA ABUS REVIEW SOFTWARE, AND USER COMPUTER/ WORK STATION THAT IS QUALIFIED TO MEET A REQUIRED SET OF HARDWARE AND SOFTWARE SPECIFICATION. IN ADDITION TO THE PROPOSED ADDITIONAL DEVICE CONFIGURATION, YOUR SUPPLEMENT REQUESTED APPROVAL OF MINOR SOFTWARE UPDATES TO ADDRESS ISSUES DISCOVERED THROUGH INTERNAL TESTING AND CUSTOMER FEEDBACK. THESE CHANGES INCLUDE MARKER POSITIONING ON IMAGES, DICOM-RELATED IMAGE CONTENT, AND GENERAL IMAGE FORMATTING, PROCESSING, AND TRANSFER. YOUR SUPPLEMENT ALSO REQUESTED LABELING CHANGES ASSOCIATED WITH THE ABOVE-SPECIFIED DEVICE CHANGE, SPECIFICALLY IN WORKSTATION USER MANUAL, SYSTEM SETUP AND BASIC SERVICE MANUAL, AND SCAN STATION MANUAL.