Identity
- Trade Name
- SOMO.V ABUS (AUTOMATED BREAST ULTRASOUND SYSTEM) FDA PMA
- Generic Name
- Automated breast ultrasound FDA PMA
Identifiers
- PMA Number
- P110006 FDA PMA
- FDA Product Code
- PAA FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Radiology FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The Invenia Abus is an automated breast ultrasound system, a type of radiology device. It is intended to increase breast cancer detection in asymptomatic women with dense breast parenchyma. The device is used as an adjunct to mammography for breast cancer screening in women with normal or benign screening mammography findings and no previous clinical breast intervention. The Invenia Abus is designed to provide a comprehensive solution for breast ultrasound examinations.
The Invenia Abus is supplied by GE Healthcare and has received FDA PMA authorization. It is classified as a class 3 device and has a product code of PAA. The device is intended for use in radiology settings and is designed to be used with women who have dense breast parenchyma and are in need of additional breast cancer screening. The Invenia Abus is available in various configurations and is designed to provide high-quality ultrasound images for breast cancer detection.
Frequently asked questions
What is the Invenia Abus used for?
The Invenia Abus is used as an adjunct to mammography for breast cancer screening in asymptomatic women with dense breast parenchyma. It is intended to increase breast cancer detection in this patient population.
What type of device is the Invenia Abus?
The Invenia Abus is an automated breast ultrasound system, a type of radiology device.
Has the Invenia Abus received FDA authorization?
Yes, the Invenia Abus has received FDA PMA authorization, as indicated by the PMA number P110006.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Invenia™ ABUS 2.0 Brustultraschall | GE HealthCare
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P110006 | Class III | Active |
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Manufacturer
- Manufacturer
- GE Healthcare
Sources (1)
- FDA PMA P110006 24 fields · synced Oct 6, 2026