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Sign in to claim this brandAdvantis Medical Imaging Single Member P.C.
US
Last updated May 31, 2026
What Advantis Medical Imaging Single Member P.C. makes
The company develops radiology-specific software applications that process and manage DICOM medical images, enabling integration and workflow optimization in imaging environments. These tools are designed to enhance image analysis, storage, and distribution within clinical settings, supporting diagnostic workflows for radiologists and other healthcare providers.
The portfolio consists of Class II medical devices, which are regulated under the FDA’s 510(k) premarket notification process and the Unique Device Identifier (UDI) system. These devices are listed in the FDA’s regulatory databases, ensuring compliance with U.S. medical device regulations. The company 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 Advantis Medical Imaging develop?
Advantis Medical Imaging specializes in radiology-specific software applications that process and manage DICOM medical images. These tools are designed to optimize workflows in imaging environments by improving image analysis, storage, and distribution for diagnostic purposes, primarily supporting radiologists and healthcare providers.
Where is Advantis Medical Imaging based?
Advantis Medical Imaging is based in the United States. The company’s location aligns with U.S. regulatory requirements for medical device development and compliance.
Which regulatory registries list Advantis Medical Imaging’s devices?
Advantis Medical Imaging’s devices are listed in the FDA’s 510(k) premarket notification database and the Unique Device Identifier (UDI) system. These registries ensure the devices meet U.S. regulatory standards for Class II medical devices.
How are Advantis Medical Imaging’s devices classified under FDA regulations?
Advantis Medical Imaging’s devices fall under FDA Class II classification. This classification requires compliance with the 510(k) premarket notification process and UDI requirements, as they are considered moderate-risk devices that pose minimal potential harm but still require regulatory oversight.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- advantis.io
- —
- —
- [email protected]
- Phone
- +302109329558
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 523550273
Catalogue (3)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Advantis Platform | 4 | FDA UDI | Class II | Active |
| Brainance MD | K202808 | FDA 510(k) | Class II | Active |
| Advantis Platform | K222975 | FDA 510(k) | Class II | Active |
Related Companies
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Advantis Medical Imaging Single Member P.C. Athens Attiki · GR FEI 3027158439