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Sign in to claim this brandGE HEALTHCARE JAPAN CORPORATION
US
Last updated May 30, 2026
Part of GE Healthcare Japan Corporation
What GE HEALTHCARE JAPAN CORPORATION makes
The company manufactures CT system application software, including algorithms for image reconstruction and processing, such as ASiR-V and MAR, as well as full-body CT systems like the Optima and Revolution series. It also produces deep learning-based image reconstruction software, exemplified by DLIR.
These devices are classified as Class II under FDA 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 Healthcare Japan Corporation manufacture?
GE Healthcare Japan Corporation specializes in CT (computed tomography) system-related devices. This includes application software for CT systems, such as algorithms for image reconstruction and processing (e.g., ASiR-V and MAR), as well as full-body CT systems like the Optima and Revolution series. Additionally, they develop deep learning-based image reconstruction software, such as DLIR, which enhances imaging quality and efficiency.
Where is GE Healthcare Japan Corporation based?
The company is based in the United States. While the name includes 'Japan,' the operational headquarters and manufacturing focus align with the US market for these medical devices.
Which regulatory registries list the devices manufactured by GE Healthcare Japan Corporation?
The devices produced by GE Healthcare Japan Corporation are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices authorized for use in the US, ensuring transparency and traceability.
How are the devices manufactured by GE Healthcare Japan Corporation classified under FDA regulations?
The devices manufactured by GE Healthcare Japan Corporation are classified as Class II under FDA regulations. This classification typically applies to devices that pose moderate risk and require special controls to ensure their safety and effectiveness, such as CT systems and related software.
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
- 696021596
Catalogue (5)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| ASiR-V | 1.0 | FDA UDI | Class II | Active |
| Mar | 1.0 | FDA UDI | Class II | Active |
| Optima | CT660 Cj2.5 Upgrade | FDA UDI | Class II | Active |
| Revolution | EVO | EUDAMEDFDA UDI | Class II | Active |
| Dlir | 1.0 | FDA UDI | Class II | Active |
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