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Device | Invenia ABUS (Automated Breast Ultrasound System) 2.0 |
Generic Name | Automated breast ultrasound |
Applicant | U-SYSTEMS, INC. 9900 WEST INNOVATIVE DRIVE MAIL STOP RP2138 WAUWATOSA, WI 53226 |
PMA Number | P110006 |
Supplement Number | S010 |
Date Received | 11/29/2017 |
Decision Date | 08/24/2018 |
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 Granted? | No |
Combination Product | No |
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). |