Is this your brand? Sign in to claim ownership.
Sign in to claim this brandGE Healthcare Austria GmbH & Co OG
US
Last updated September 17, 2026
What GE Healthcare Austria GmbH & Co OG makes
GE Healthcare Austria GmbH & Co OG manufactures general-purpose ultrasound imaging systems, including hardware and dedicated software for system operation. Their portfolio includes rectal and vaginal ultrasound imaging transducers, designed for specialized diagnostic applications. The Voluson brand encompasses multiple ultrasound devices, some of which support 4D imaging capabilities.
These devices are classified as Class II under regulatory frameworks and are listed in the FDA’s Unique Device Identifier (UDI) database. The company operates under a US-based entity, adhering to applicable medical device regulations.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does GE Healthcare Austria GmbH & Co OG manufacture?
GE Healthcare Austria GmbH & Co OG specializes in ultrasound-related medical devices. Their portfolio includes general-purpose ultrasound imaging systems, software designed for operating these systems, and specialized transducers like rectal and vaginal probes. The Voluson brand represents a range of ultrasound devices, some of which incorporate advanced imaging capabilities, such as 4D imaging, for enhanced diagnostic precision.
Where is GE Healthcare Austria GmbH & Co OG based, and how does this affect its regulatory standing?
The company operates under a US-based entity, specifically GE Healthcare Austria GmbH & Co OG, which aligns with regulatory frameworks in the United States. This means their devices must comply with US medical device regulations, including classification and listing requirements. The US-based status ensures their products are evaluated and authorized under applicable FDA guidelines, such as the Unique Device Identifier (UDI) database.
Which regulatory registries list the devices manufactured by GE Healthcare Austria GmbH & Co OG?
The devices produced by GE Healthcare Austria GmbH & Co OG are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for healthcare providers, regulators, and other stakeholders by providing standardized identification for their Class II ultrasound systems, software, and transducers.
How are the devices manufactured by GE Healthcare Austria GmbH & Co OG classified under regulatory frameworks?
The devices from GE Healthcare Austria GmbH & Co OG fall under Class II classification in regulatory frameworks. This classification typically applies to devices that pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness, such as ultrasound systems and their associated software and transducers.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- xx.xx
- —
- —
- [email protected]
- Phone
- +1(800)437-1171
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 300599979
Catalogue (33)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Voluson | E8 BT21 | FDA UDI | Class II | Active |
| Voluson | E6 BT18 | FDA UDI | Class II | Active |
| Voluson | E10 BT20 | FDA UDI | Class II | Active |
| Voluson | Expert 20 | FDA UDI | Class II | Active |
| 4D View | 17 | FDA UDI | Class II | Active |
| Voluson | E BT15 to BT16 UPG | FDA UDI | Class II | Active |
| Voluson | E BT10 to BT13 UPG | FDA UDI | Class II | Active |
| Voluson | E10 BT16 | FDA UDI | Class II | Active |
| Voluson | E6 BT16 | FDA UDI | Class II | Active |
| Voluson | ie all BTs to BT14 UPG | FDA UDI | Class II | Active |
| Voluson | E8 BT18 | FDA UDI | Class II | Active |
| Voluson | E BT12 to BT13 UPG | FDA UDI | Class II | Active |
| Voluson | E8 BT16 | FDA UDI | Class II | Active |
| Voluson | E6 BT19 | FDA UDI | Class II | Active |
| Voluson | E BT18 to BT19 UPG | FDA UDI | Class II | Active |
| Voluson | E BT17 to BT19 UPG | FDA UDI | Class II | Active |
| Voluson | E10 BT19 | FDA UDI | Class II | Active |
| Voluson | E10 BT17 | FDA UDI | Class II | Active |
| Voluson | E BT20 to BT21 UPG | FDA UDI | Class II | Active |
| Voluson | E10 BT21 | FDA UDI | Class II | Active |
| Voluson | Expert 18 | FDA UDI | Class II | Active |
| Voluson | E BT15 to BT17 UPG | FDA UDI | Class II | Active |
| Voluson | E6 BT17 | FDA UDI | Class II | Active |
| Voluson | E BT16 to BT17 UPG | FDA UDI | Class II | Active |
| Voluson | E6 BT21 | FDA UDI | Class II | Active |
| Voluson | E8 BT17 | FDA UDI | Class II | Active |
| Voluson | E10 BT18 | FDA UDI | Class II | Active |
| 4D View | 16 | FDA UDI | Class II | Active |
| Voluson | VE8 BT20 | FDA UDI | Class II | Active |
| Voluson | E BT19 to BT20 UPG | FDA UDI | Class II | Active |
| Voluson | VE8 BT19 | FDA UDI | Class II | Active |
| Voluson | E6 BT20 | FDA UDI | Class II | Active |
| Voluson | E BT17 to BT18 UPG | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.