Invenia ABUS (Automated Breast Ultrasound System) 2.0

Automated Breast Ultrasound

FDA Premarket Approval P110006 S010

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

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).

• Device: Invenia ABUS (Automated Breast Ultrasound System) 2.0
• Classification Name: Automated Breast Ultrasound
• Generic Name: Automated Breast Ultrasound
• Applicant: U-SYSTEMS, INC.
• Date Received: 2017-11-29
• Decision Date: 2018-08-24
• PMA: P110006
• Supplement: S010
• Product Code: PAA
• Advisory Committee: Radiology
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Location Change - Manufacturer/sterilizer/packager/supplier
• Expedited Review: No
• Combination Product: No
• Applicant Address: U-SYSTEMS, INC. 9900 West Innovative Drive mail Stop Rp2138 wauwatosa, WI 53226

Supplemental Filings

Supplement Number	Date	Supplement Type
P110006		Original Filing
S010	2017-11-29	Normal 180 Day Track No User Fee
S009	2017-11-28	Normal 180 Day Track
S008	2017-02-28	Normal 180 Day Track No User Fee
S007	2016-08-03	Normal 180 Day Track
S006	2015-09-18	30-day Notice
S005	2015-02-27	Real-time Process
S004	2014-11-03	Real-time Process
S003	2014-02-26	30-day Notice
S002	2014-01-17	Real-time Process
S001	2013-03-07	Normal 180 Day Track

NIH GUDID Devices

Device ID	PMA	Supp
00840682100038	P110006	001
00840682100021	P110006	001
00840682100014	P110006	001
00840682100090	P110006	004
00840682141161	P110006	009