Invenia ABUS 2.0 Automated Breast Ultrasound System
FDA premarket approval P110006/S009 · decided 2018-05-11
Approval details
- PMA number
- P110006
- Supplement
- S009
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Invenia ABUS 2.0 Automated Breast Ultrasound System
- Generic name
- Automated breast ultrasound
- Applicant
- GE Healthcare
- Date received
- 2017-11-28
- Decision date
- 2018-05-11
- Days to decision
- 164 days
- Decision code
- APPR
- Product code
- PAA
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Wauwatosa, WI
- 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.
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