PMA P110006S011

Device: Invenia ABUS Premium, Invenia ABUS Prime
Applicant: GE Healthcare
PMA number: P110006
Supplement: S011
Product code: PAA
Decision date: 2025-02-04
Classification: Radiology
Generic name: Automated breast ultrasound
Approval order statement: The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has completed its review of your premarket approval application (PMA) 180-day supplement, which requested approval for modification of the currently-approved transducer, addition of a new transducer, hardware changes, addition of two new device names, and addition of two new features: Auto Nipple Detection, and Scan Quality Assessment.

Current openFDA PMA Record#

Device: Invenia ABUS Premium, Invenia ABUS Prime
Applicant: GE Healthcare
PMA number: P110006
Supplement: S011
Product code: PAA
Generic name: Automated breast ultrasound
Decision date: 2025-02-04
Decision code: APPR
Date received: 2024-07-15
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has completed its review of your premarket approval application (PMA) 180-day supplement, which requested approval for modification of the currently-approved transducer, addition of a new transducer, hardware changes, addition of two new device names, and addition of two new features: Auto Nipple Detection, and Scan Quality Assessment.