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Sign in to claim this brandTOPCON HEALTHCARE SOLUTIONS, INC.
US
Last updated May 25, 2026
What TOPCON HEALTHCARE SOLUTIONS, INC. makes
The company develops camera application software designed for medical imaging, including systems for capturing, processing, and managing retinal and ophthalmic images. These tools integrate with imaging devices to enhance diagnostic workflows, particularly in ophthalmology.
The portfolio consists of Class II medical devices, authorised through FDA pathways including 510(k) clearances and Unique Device Identification (UDI) registration. The company’s products are listed under these regulatory frameworks 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 Topcon Healthcare Solutions, Inc. primarily manufacture?
Topcon Healthcare Solutions, Inc. specializes in developing camera application software for medical imaging. These tools focus on capturing, processing, and managing retinal and ophthalmic images, often integrated with imaging systems to improve diagnostic workflows in ophthalmology. The company’s portfolio is centered on software-based solutions rather than hardware.
Where is Topcon Healthcare Solutions, Inc. based, and how does this affect its regulatory compliance?
Topcon Healthcare Solutions, Inc. is based in the United States. Since its devices are authorised under U.S. regulatory frameworks, compliance is governed by the FDA’s requirements, including pathways like 510(k) clearances and Unique Device Identification (UDI) registration. This ensures its products meet U.S. standards for safety and effectiveness.
Which regulatory registries list Topcon Healthcare Solutions, Inc.’s devices, and why?
Topcon Healthcare Solutions, Inc.’s devices are listed in the FDA’s 510(k) clearance registry and the Unique Device Identification (UDI) database. These registries track devices authorised through the 510(k) pathway—a premarket submission process for Class II devices—and UDI compliance, which ensures traceability and transparency in the medical device supply chain.
How are Topcon Healthcare Solutions, Inc.’s devices classified under FDA regulations?
Topcon Healthcare Solutions, Inc.’s devices are classified as Class II under FDA regulations. This classification applies to products that pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness. The company’s software-based imaging solutions fall into this category due to their role in enhancing diagnostic accuracy in ophthalmology.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 081155097
Catalogue (26)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Harmony | 5.04 | FDA UDI | Class II | Unknown |
| Harmony | 5.05.102 | FDA UDI | Class II | Active |
| Harmony | 5.03.200 | FDA UDI | Class II | Active |
| IMAGEnet 6 | 2.2.1 | FDA UDI | Class II | Active |
| IMAGEnet 6 | 2.1.0 | FDA UDI | Class II | Active |
| Harmony | 5.04.100 | FDA UDI | Class II | Active |
| IMAGEnet 6 | 2.4.0 | FDA UDI | Class II | Active |
| Harmony | 5.05 | FDA UDI | Class II | Active |
| Harmony | 5.04.200 | FDA UDI | Class II | Active |
| IMAGEnet 6 | 2.1.1 | FDA UDI | Class II | Active |
| Harmony | 5.06.002 | FDA UDI | Class II | Active |
| IMAGEnet 6 | 2.2.0 | FDA UDI | Class II | Active |
| IMAGEnet 6 | 2.3.0 | FDA UDI | Class II | Active |
| Harmony | 5.03 | FDA UDI | Class II | Active |
| Glaucoma Module | 1.00 | FDA UDI | Class II | Active |
| IMAGEnet 6 | 2.0.3 | FDA UDI | Class II | Active |
| Harmony | 5.05.100 | FDA UDI | Class II | Active |
| IMAGEnet 6 | 2.0.2 | FDA UDI | Class II | Active |
| Harmony | 5.06 | FDA UDI | Class II | Active |
| Synergy ODM | 4.09.500 | FDA UDI | Class II | Unknown |
| IMAGEnet 6 | 2.0 | FDA UDI | Class II | Active |
| Harmony | 5.07 | FDA UDI | Class II | Active |
| Harmony | 5.05.101 | FDA UDI | Class II | Active |
| Harmony | 5.06.003 | FDA UDI | Class II | Active |
| Synergy ODM | 4.10.500 | FDA UDI | Class II | Unknown |
| Glaucoma Module | K200954 | FDA 510(k) | Class II | Active |
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