INVENIA ABUS-AUTOMATED BREAST ULTRASOUND SYSTEM

Automated Breast Ultrasound

FDA Premarket Approval P110006 S004

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 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.

• Device: INVENIA ABUS-AUTOMATED BREAST ULTRASOUND SYSTEM
• Classification Name: Automated Breast Ultrasound
• Generic Name: Automated Breast Ultrasound
• Applicant: U-SYSTEMS, INC.
• Date Received: 2014-11-03
• Decision Date: 2014-11-24
• PMA: P110006
• Supplement: S004
• Product Code: PAA
• Advisory Committee: Radiology
• Supplement Type: Real-time Process
• Supplement Reason: Change Design/components/specifications/material
• 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