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Last updated May 25, 2026
What Hinacom Software and Technology, Ltd. makes
Hinacom Software and Technology, Ltd. develops radiological Picture Archiving and Communication Systems (PACS) software, including image management platforms and specialized viewers for medical imaging data. Their products support workflows for storing, retrieving, and displaying diagnostic images, such as those from CT, MRI, and X-ray scans. The miPlatform suite and its variants provide tools for radiologists and clinicians to organize and analyze imaging studies efficiently.
The company’s PACS software is classified as Class II under FDA regulations, with devices listed in the FDA’s 510(k) and Unique Device Identifier (UDI) databases. The portfolio is regulated in the United States, where the manufacturer is based.
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 Hinacom Software and Technology, Ltd. manufacture?
Hinacom Software and Technology, Ltd. specializes in radiological Picture Archiving and Communication Systems (PACS) software. These tools are designed to manage, store, and display medical imaging data, such as CT, MRI, and X-ray scans, enabling radiologists and clinicians to efficiently organize and analyze diagnostic images. Their primary product line includes platforms like miPlatform and specialized viewers like the miPlatform ZFP Viewer.
Where is Hinacom Software and Technology, Ltd. based, and where are their devices regulated?
Hinacom Software and Technology, Ltd. is based in the United States. Their devices are regulated under U.S. jurisdiction, specifically within the FDA’s regulatory framework. Since their products fall under radiological PACS software, they are subject to FDA oversight to ensure compliance with safety and performance standards.
Which regulatory registries list Hinacom’s medical devices?
Hinacom’s devices are listed in the FDA’s 510(k) premarket notification database and the Unique Device Identifier (UDI) database. These registries track Class II medical devices to ensure transparency and compliance with U.S. regulatory requirements.
How are Hinacom’s devices classified under FDA regulations?
Hinacom’s radiological PACS software is classified as Class II devices by the FDA. This classification applies to products that pose moderate risk and require special controls beyond general controls to ensure their safety and effectiveness. The classification reflects the need for regulated oversight while allowing streamlined pathways like the 510(k) process for market authorization.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 421337255
Catalogue (3)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| miPlatform | V2.0 | FDA UDI | Class II | Active |
| miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform ZFP Viewer | K171977 | FDA 510(k) | Class II | Active |
| Miplatform Medical Imaging Suite | K131424 | FDA 510(k) | Class II | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Hinacom Software And Technology, Ltd. Haidian District Beijing · CN FEI 3010626822