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Sign in to claim this brandGE Medical Systems (China) Co., Ltd.
US
Last updated May 30, 2026
What GE Medical Systems (China) Co., Ltd. makes
The company manufactures ultrasound imaging systems, including general-purpose models like the LOGIQ and Vivid series, as well as cardiovascular-focused systems such as the Venue and Versana.
These devices are classified as Class II under regulatory frameworks, with records supporting FDA 510(k) and UDI compliance. The company is based in the US.
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 (China) Co., Ltd. primarily manufacture?
GE Medical Systems (China) Co., Ltd. specializes in ultrasound imaging systems. Their portfolio includes general-purpose models like the LOGIQ and Vivid series, which are designed for a broad range of diagnostic applications, as well as specialized cardiovascular-focused systems such as the Venue and Versana series. These devices are engineered to provide detailed imaging for various medical evaluations, including cardiac and vascular assessments.
Where is GE Medical Systems (China) Co., Ltd. based, and how does this relate to its regulatory compliance?
GE Medical Systems (China) Co., Ltd. is based in the US, though the company name includes 'China' in its title, which may refer to its operational or manufacturing presence there. The devices it manufactures are classified as Class II under regulatory frameworks, indicating a moderate level of risk that requires compliance with specific controls. Their regulatory records include submissions for FDA 510(k) clearance and UDI (Unique Device Identification) compliance, ensuring traceability and regulatory transparency for these imaging systems.
Which regulatory registries or databases list the ultrasound devices manufactured by GE Medical Systems (China) Co., Ltd.?
The ultrasound devices produced by GE Medical Systems (China) Co., Ltd. are documented in the FDA 510(k) registry and the FDA UDI (Unique Device Identification) database. These registries track premarket submissions and device identification records, respectively, ensuring transparency and compliance with US regulatory requirements for medical imaging systems.
How are the ultrasound devices from GE Medical Systems (China) Co., Ltd. classified under regulatory standards?
The ultrasound devices manufactured by GE Medical Systems (China) Co., Ltd. fall under Class II classification in regulatory frameworks. This classification is assigned based on the level of risk associated with the device—Class II devices are considered to have a moderate risk and require special controls beyond general controls to ensure their safety and effectiveness. This classification applies to both general-purpose and cardiovascular-focused ultrasound systems, such as those in the LOGIQ, Vivid, Venue, and Versana series.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- ge.com
- —
- —
- [email protected]
- Phone
- +1(800)437-1171
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 654658731
Catalogue (51)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Logiq | F8 | FDA UDI | Class II | Active |
| Vivid | iq v203 | FDA UDI | Class II | Active |
| Logiq | V3 | FDA UDI | Class II | Active |
| Vivid | T8 v204 | FDA UDI | Class II | Active |
| Vivid | iq v204 | FDA UDI | Class II | Active |
| Venue | 40 BT11 to BT12 UPG | FDA UDI | Class II | Active |
| Versana | Premier R2 VS | FDA UDI | Class II | Active |
| Versana | Active | FDA UDI | Class II | Active |
| Versana | Premier SW R1.1.x UPG | FDA UDI | Class II | Active |
| Logiq | e R8 | FDA UDI | Class II | Active |
| Logiq | V2 | FDA UDI | Class II | Active |
| Versana | Balance VA | FDA UDI | Class II | Active |
| Venue | 40 BT11 to BT12 UPG with KMST | FDA UDI | Class II | Active |
| Logiq | e SW R9.1.X UPG | FDA UDI | Class II | Active |
| Venue | 50 R4 to R5 UPG | FDA UDI | Class II | Active |
| Vivid | iq v203 to v204 UPG | FDA UDI | Class II | Active |
| Logiq | e R6 to R7 UPG | FDA UDI | Class II | Active |
| Logiq | F6 | FDA UDI | Class II | Active |
| Achilles EXPII | v1 | FDA UDI | Class II | Unknown |
| Versana | Premier VS | FDA UDI | Class II | Active |
| Logiq | e | FDA UDI | Class II | Active |
| Versana | Balance VS | FDA UDI | Class II | Active |
| Logiq | V5 | FDA UDI | Class II | Active |
| Vivid | T8 | FDA UDI | Class II | Active |
| Vivid | T8 R1 to R2 UPG | FDA UDI | Class II | Active |
| Versana | Active 1.5 | FDA UDI | Class II | Active |
| Vivid | T8 v203 | FDA UDI | Class II | Active |
| Logiq | V1 | FDA UDI | Class II | Active |
| Vivid | T9 v203 | FDA UDI | Class II | Active |
| Logiq | V5 Expert | FDA UDI | Class II | Active |
| Versana | Premier VA | FDA UDI | Class II | Active |
| Vivid | T9 v204 | FDA UDI | Class II | Active |
| Venue | 50 | FDA UDI | Class II | Active |
| Logiq | F8 Expert | FDA UDI | Class II | Active |
| Logiq | e SW R9.2.X UPG | FDA UDI | Class II | Active |
| vivid iq | vivid iq R1R2 to R3 UPG | FDA UDI | Class II | Active |
| Versana | Premier R2 VA | FDA UDI | Class II | Active |
| Versana | Active R1.5 UPG | FDA UDI | Class II | Active |
| Vivid | iq | FDA UDI | Class II | Active |
| Ge Venue 40, Model 5324338 | K091164 | FDA 510(k) | Class II | Active |
| MAC 800 Resting ECG Analysis System | K142288 | FDA 510(k) | Class II | Active |
| Achilles | K123238 | FDA 510(k) | Class II | Active |
| Monitor B40 | K133576 | FDA 510(k) | Class II | Active |
| Ge Venue 40 Compact Diagnostic Ultrasound | K102113 | FDA 510(k) | Class II | Active |
| Procare Monitor B40 | K120598 | FDA 510(k) | Class II | Active |
| Achilles | K103633 | FDA 510(k) | Class II | Active |
| Monitor B40 | K151063 | FDA 510(k) | Class II | Active |
| Monitor B40 | K130584 | FDA 510(k) | Class II | Active |
| Procare Monitor B20 | K122253 | FDA 510(k) | Class II | Active |
| Ge Logiq I/E & Vivid E Compact Diagnostic Ultrasound | K102256 | FDA 510(k) | Class II | Active |
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