PMA P110006S010

Device: Invenia ABUS (Automated Breast Ultrasound System) 2.0
Applicant: GE Healthcare
PMA number: P110006
Supplement: S010
Product code: PAA
Decision date: 2018-08-24
Classification: Automated Breast Ultrasound
Generic name: Automated breast ultrasound
Approval order statement: Approval for a manufacturing site in Wuxi, China for U-Systems Invenia ABUS (Automated Breast Ultrasound System) 2.0, which includes a Scan Station (with automated transducer).

Current openFDA PMA Record#

Device: Invenia ABUS (Automated Breast Ultrasound System) 2.0
Applicant: GE Healthcare
PMA number: P110006
Supplement: S010
Product code: PAA
Generic name: Automated breast ultrasound
Decision date: 2018-08-24
Decision code: APPR
Date received: 2017-11-29
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for a manufacturing site in Wuxi, China for U-Systems Invenia ABUS (Automated Breast Ultrasound System) 2.0, which includes a Scan Station (with automated transducer).