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).

DeviceInvenia ABUS (Automated Breast Ultrasound System) 2.0
Classification NameAutomated Breast Ultrasound
Generic NameAutomated Breast Ultrasound
ApplicantU-SYSTEMS, INC.
Date Received2017-11-29
Decision Date2018-08-24
PMAP110006
SupplementS010
Product CodePAA
Advisory CommitteeRadiology
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonLocation Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address U-SYSTEMS, INC. 9900 West Innovative Drive mail Stop Rp2138 wauwatosa, WI 53226

Supplemental Filings

Supplement NumberDateSupplement Type
P110006Original 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 IDPMASupp
00840682100038 P110006 001
00840682100021 P110006 001
00840682100014 P110006 001
00840682100090 P110006 004
00840682141161 P110006 009

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