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Sign in to claim this brandSingular Health Pty, Ltd.
US
Last updated May 31, 2026
What Singular Health Pty, Ltd. makes
Singular Health Pty, Ltd. manufactures radiology workstations designed for medical imaging, including DICOM-compatible systems for viewing, storing, and managing diagnostic images. Their products support 3D visualization and cloud-based access for radiology workflows.
The company’s devices are classified as Class II under FDA regulations and are listed in the FDA’s 510(k) and UDI registries. The portfolio is authorised for use 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 Singular Health Pty, Ltd. manufacture?
Singular Health Pty, Ltd. specializes in radiology picture archiving and communication system (PACS) workstations. These devices are designed to store, view, and manage medical imaging data, including DICOM-compatible images. Their products also support advanced features like 3D visualization and cloud-based access, helping streamline radiology workflows.
Where is Singular Health Pty, Ltd. based, and what region do their devices serve?
Singular Health Pty, Ltd. is based in the United States. Their devices are authorised for use in the U.S. market, as indicated by their classification and regulatory listings.
Which regulatory registries list Singular Health Pty, Ltd.’s devices?
Singular Health Pty, Ltd.’s devices are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) registries. These registries track medical devices that have undergone the required premarket notification process and are assigned a UDI for traceability.
How are Singular Health Pty, Ltd.’s devices classified under FDA regulations?
Singular Health Pty, Ltd.’s devices fall under Class II classification by the FDA. This classification is typically assigned to devices that pose moderate risk and require special controls to ensure safety and effectiveness, such as PACS workstations, which require validation for performance and usability.
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
- 746825698
Catalogue (3)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| 3Dicom MD | 3Dicom MD | FDA UDI | Class II | Active |
| 3DICOM MD Cloud | K253784 | FDA 510(k) | Class II | Active |
| 3Dicom MD | K222470 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
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Authorities
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Singular Health Pty Ltd Leederville Western Australia · AU FEI 3024078470