PMA P110006S001

Device: SOMO-V AUTOMATED BREAST ULTRASOUND SYSTEM
Applicant: GE Healthcare
PMA number: P110006
Supplement: S001
Product code: PAA
Decision date: 2013-06-17
Classification: Automated Breast Ultrasound
Generic name: Automated breast ultrasound
Approval order statement: APPROVAL FOR A NEW TRANSDUCER, NEW PRE-SET COMPRESSION ASSIST FUNCTION, AND OTHER SOFTWARE AND COMPUTER HARDWARE CHANGES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME INVENIA ABUS AND IS INDICATED AS AN ADJUNCT TO MAMMOGRAPHY FOR BREASTCANCER SCREENING IN ASYMPTOMATIC WOMAN FOR WHOM SCREENING MAMMOGRAPHY FINDINGS ARE NORMAL OR BENIGN (BI-RADS ASSESSMENT CATEGORY 1 OR 2), WITH DENSE BREAST PARENCHYMA (BIRADSCOMPOSITION/DENSITY 3 OR 4), AND HAVE NOT HAD PREVIOUS CLINICAL BREAST INTERVENTION. THE DEVICE IS INTENDED TO INCREASE BREAST CANCER DETECTION IN THE DESCRIBED PATIENT POPULATION.

Current openFDA PMA Record#

Device: SOMO-V AUTOMATED BREAST ULTRASOUND SYSTEM
Applicant: GE Healthcare
PMA number: P110006
Supplement: S001
Product code: PAA
Generic name: Automated breast ultrasound
Decision date: 2013-06-17
Decision code: APPR
Date received: 2013-03-07
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR A NEW TRANSDUCER, NEW PRE-SET COMPRESSION ASSIST FUNCTION, AND OTHER SOFTWARE AND COMPUTER HARDWARE CHANGES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME INVENIA ABUS AND IS INDICATED AS AN ADJUNCT TO MAMMOGRAPHY FOR BREASTCANCER SCREENING IN ASYMPTOMATIC WOMAN FOR WHOM SCREENING MAMMOGRAPHY FINDINGS ARE NORMAL OR BENIGN (BI-RADS ASSESSMENT CATEGORY 1 OR 2), WITH DENSE BREAST PARENCHYMA (BIRADSCOMPOSITION/DENSITY 3 OR 4), AND HAVE NOT HAD PREVIOUS CLINICAL BREAST INTERVENTION. THE DEVICE IS INTENDED TO INCREASE BREAST CANCER DETECTION IN THE DESCRIBED PATIENT POPULATION.