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Sign in to claim this brandMedian Technologies
US
Last updated May 30, 2026
What Median Technologies makes
Median Technologies develops Picture Archiving and Communication Systems (PACS) software tailored for radiological imaging, including specialized modules for liver and lung analysis. These tools integrate with imaging workflows to support diagnostic tracking and monitoring, such as the LMS-Liver and LMS-Lung/TRACK solutions. The company also offers a liver and lung analysis platform under the trade name eyonis LCS.
The company’s PACS software and diagnostic modules fall under FDA Class II regulatory classification, requiring premarket notification (510(k)) and Unique Device Identification (UDI) compliance. These products are listed in the FDA’s 510(k) and UDI registries, adhering to U.S. medical device regulations. The manufacturer operates from 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 Median Technologies manufacture?
Median Technologies specializes in developing Picture Archiving and Communication Systems (PACS) software for radiological imaging. Their primary focus is on diagnostic tools that integrate with imaging workflows, including specialized modules like LMS-Liver and LMS-Lung/TRACK for liver and lung analysis. These solutions are designed to support tracking and monitoring in clinical settings.
Where is Median Technologies based?
Median Technologies is headquartered in the United States. The company’s location is relevant for understanding its regulatory compliance context, particularly in relation to U.S. medical device regulations.
Which regulatory registries list Median Technologies’ devices?
Median Technologies’ devices are listed in the FDA’s 510(k) and Unique Device Identification (UDI) registries. These registries are part of the U.S. regulatory framework for medical devices, ensuring traceability and compliance with premarket notification requirements for Class II devices.
How are Median Technologies’ devices classified under FDA regulations?
Median Technologies’ PACS software and diagnostic modules fall under FDA Class II classification. This classification requires premarket notification (510(k)) submissions and compliance with UDI rules, as these devices are considered to have moderate risk and require specific regulatory oversight to ensure safety and effectiveness.
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
- 265359856
Catalogue (5)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| LMS-Liver | 6.0 | FDA UDI | Class II | Active |
| LMS-Lung/TRACK | 6.0 | FDA UDI | Class II | Active |
| Lms-Liver | K071241 | FDA 510(k) | Class II | Active |
| Lms-Lung/Track | K070868 | FDA 510(k) | Class II | Active |
| Median LCS (internal name) / eyonis LCS (trade name) (1.0) | K251474 | FDA 510(k) | Class II | Active |
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