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Sign in to claim this brandGE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC
US
Last updated September 17, 2026
What GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC makes
The company manufactures general-purpose ultrasound imaging systems for diagnostic imaging, including handheld and portable models for primary care settings. It also produces dual-energy X-ray absorptiometry systems for bone density measurements and dedicated breast ultrasound imaging devices.
These devices are classified under FDA’s Class II and Class III regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. The company is based in the United States.
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 Medical Systems, Ultrasound & Primary Care Diagnostics, LLC manufacture?
The company produces general-purpose ultrasound imaging systems, including portable and handheld models designed for primary care settings. It also makes dual-energy X-ray absorptiometry (DEXA) systems for measuring bone density and specialized breast ultrasound imaging devices. These devices are intended for diagnostic and screening purposes.
Where is GE Medical Systems, Ultrasound & Primary Care Diagnostics, LLC based?
The company is headquartered in the United States. While the exact location isn’t specified, its operations and manufacturing are conducted within the country.
Which regulatory registries or databases list the company’s devices?
The company’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices authorized for use in the U.S. by assigning a standardized identifier to each product.
How are the company’s devices classified under FDA regulations?
The company’s devices fall under FDA’s Class II and Class III classifications. Class II devices generally pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness, while Class III devices are those with the highest risk and require pre-market approval due to insufficient data from general or special controls alone.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- 3030 Ohmeda Drive, MADISON, WI, 53718
- Website
- xx.xx
- —
- —
- [email protected]
- Phone
- +1(800)437-1171
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 2183066
- DUNS Number
- 078863378
Catalogue (14)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Lunar iDXA | F1 | FDA UDI | Class II | Active |
| Prodigy | F1 | FDA UDI | Class II | Active |
| Venue GO | R3 UPG | FDA UDI | Class II | Active |
| Logiq | E9 R4 to R5 UPG | FDA UDI | Class II | Unknown |
| Prodigy | F2 | FDA UDI | Class II | Active |
| Invenia | ABUS System | FDA UDI | Class III | Unknown |
| Venue | R2 | FDA UDI | Class II | Active |
| Invenia | ABUS Workstation | FDA UDI | Class III | Active |
| Logiq E9 | 5205000-8 | FDA UDI | Class II | Unknown |
| Venue Go | R4 | FDA UDI | Class II | Active |
| Logiq | E9 R5 to XDclear 2.0 UPG | FDA UDI | Class II | Active |
| Venue | R3 | FDA UDI | Class II | Active |
| Venue | R1 | FDA UDI | Class II | Active |
| Venue Go | R2 | FDA UDI | Class II | Active |
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