PMA P110006S009

Device

Invenia ABUS 2.0 Automated Breast Ultrasound System

Applicant

GE Healthcare

PMA number

P110006

Supplement

S009

Product code

PAA

Decision date

2018-05-11

Classification

Automated Breast Ultrasound

Generic name

Automated breast ultrasound

Approval order statement

Approval for changes to the Invenia ABUS 2.0 Automated Breast Ultrasound System include hardware updates which include a new ultrasound beam former, ultrasound engine, and computer components. This supplement also requests approval for removal of the current review software from the PMA, and proposes that the images will now be reviewed on a workstation.

Summary

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