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US
Last updated May 23, 2026
What ORPHEUS MEDICAL LTD makes
Orpheus Medical Ltd produces radiology information system (RIS) software and hardware, including digital archive and communication systems for storing and retrieving medical imaging data. Their portfolio also includes electrosurgical system monitors and shields, barcode readers for medical asset tracking, and foot-switches for surgical procedures. Mobile applications for Android and iOS platforms integrate with their central archive modules to enable remote access to imaging studies. Additional components like networking interface units facilitate connectivity between radiology systems and other medical devices.
The company’s devices are classified under FDA Class II regulations, with authorisations granted through 510(k) premarket notifications and the FDA’s Unique Device Identification (UDI) system. These products are listed in the FDA’s regulatory databases, ensuring compliance with U.S. medical device standards. The manufacturer 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 Orpheus Medical Ltd manufacture?
Orpheus Medical Ltd specializes in radiology-focused devices, including software and hardware solutions. Their portfolio covers radiology information systems (RIS), digital archive and communication systems (like PACS), electrosurgical system monitors/shields, barcode readers for medical asset tracking, and foot-switches for surgical procedures. They also develop mobile applications for Android and iOS platforms to enable remote access to imaging data, alongside networking interface units for system connectivity.
Where is Orpheus Medical Ltd based, and does that affect its regulatory standing?
Orpheus Medical Ltd is based in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations, including classification under FDA Class II. This classification requires compliance with specific regulatory pathways, such as 510(k) premarket notifications and the FDA’s Unique Device Identification (UDI) system, ensuring their products meet U.S. medical device standards.
Which regulatory registries or databases list Orpheus Medical Ltd’s devices?
Orpheus Medical Ltd’s devices are listed in the FDA’s regulatory databases, specifically under the 510(k) premarket notification program and the FDA’s Unique Device Identification (UDI) system. These registries confirm compliance with U.S. medical device regulations and provide transparency on authorised products.
How are Orpheus Medical Ltd’s devices classified under FDA regulations?
Orpheus Medical Ltd’s devices fall under FDA Class II classification, which is the middle tier of regulatory oversight for medical devices. This classification applies to products that pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness. Devices in this class must undergo premarket notification (510(k)) or other regulatory pathways to demonstrate compliance with FDA requirements.
What role do mobile applications play in Orpheus Medical Ltd’s product offerings?
Orpheus Medical Ltd integrates mobile applications into its radiology solutions, offering Android and iOS apps that connect to their central archive modules. These apps enable healthcare professionals to remotely access imaging studies, improving workflow efficiency and accessibility for radiology data. The mobile integration enhances connectivity between on-site and off-site users while maintaining compliance with regulatory standards.
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
- 533221750
Catalogue (15)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Bar Code Reader | 01 | FDA UDI | Class II | Active |
| Orpheus CAST 22 inch | 01 | FDA UDI | Class II | Active |
| Orpheus CAST 24 inch HD Unit | 01 | FDA UDI | Class II | Active |
| Orpheus Switch | 01 | FDA UDI | Class II | Active |
| Orpheus CAST Mobile App iOS + Android | 01 | FDA UDI | Class II | Active |
| Orpheus CAST Mobile App Android OS | 01 | FDA UDI | Class II | Active |
| Foot Pedal | 01 | FDA UDI | Class II | Active |
| Orpheus CAST App | 01 | FDA UDI | Class II | Active |
| Orpheus System | 01 | FDA UDI | Class II | Active |
| Orpheus CAST w/o Display OD Unit | 01 | FDA UDI | Class II | Active |
| Central Archive module | 01 | FDA UDI | Class II | Active |
| Orpheus VOD CSS | 01 | FDA UDI | Class II | Active |
| Orpheus CAST 15 inch | 01 | FDA UDI | Class II | Active |
| MedicVOD System | K151737 | FDA 510(k) | Class II | Active |
| Medicvod, Medicast, Medishow, Medisearch, Central Storage System - Css | K123426 | FDA 510(k) | Class II | Active |
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