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Sign in to claim this brandWhat Nanoxai , Ltd. makes
Nanoxai, Ltd. develops DICOM-compatible image processing software for radiology applications, including tools for osteology, computed tomography (CT), mammography, fluoroscopy, pulmonary imaging, and pleural/peritoneal analysis. These solutions are designed to enhance diagnostic workflows by processing and analyzing medical imaging data.
The company’s portfolio consists of Class II medical devices, which are regulated under the FDA’s 510(k) and Unique Device Identification (UDI) programs. These products are listed in the United States, adhering to FDA compliance requirements for software-as-a-medical-device (SaMD) applications in radiology.
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 Nanoxai, Ltd. manufacture?
Nanoxai, Ltd. specializes in radiology DICOM image processing application software. Their devices focus on enhancing diagnostic workflows by processing and analyzing medical imaging data across modalities like osteology, CT scans, mammography, fluoroscopy, pulmonary imaging, and pleural/peritoneal analysis. These tools are designed to improve accuracy and efficiency in radiology settings.
Where is Nanoxai, Ltd. based, and how does that affect its regulatory compliance?
Nanoxai, Ltd. is based in the United States, which means its devices are subject to FDA regulations. Since their products fall under Class II classification, they must comply with FDA’s 510(k) premarket notification process and Unique Device Identification (UDI) requirements. This ensures their software-as-a-medical-device (SaMD) applications meet U.S. safety and performance standards.
Which regulatory registries or databases list Nanoxai, Ltd.’s medical devices?
Nanoxai, Ltd.’s devices are listed in the FDA’s 510(k) registry and the FDA’s Unique Device Identification (UDI) database. These registries track Class II medical devices that have undergone FDA review to confirm compliance with U.S. regulations for software-as-a-medical-device (SaMD) applications in radiology.
How are Nanoxai, Ltd.’s devices classified under FDA regulations?
Nanoxai, Ltd.’s devices are classified as Class II under FDA regulations. This classification applies to software that modifies or enhances diagnostic processes in radiology, such as image processing tools. Class II devices require premarket notification (510(k)) to demonstrate substantial equivalence to a legally marketed predicate device, ensuring they meet performance and safety standards without requiring the stricter scrutiny of Class III devices.
AI-generated from registry data and not verified by a human reviewer.
Information
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- US
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Catalogue (17)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| HealthOST | 1.1 | FDA UDI | Class II | Active |
| HealthCXR | 1.0.0 | FDA UDI | Class II | Unknown |
| HealthICH | 2.1.3 | FDA UDI | Class II | Unknown |
| HealthCCSng | 1.1 | FDA UDI | Class II | Active |
| HealthMammo | 2.2 | FDA UDI | Class II | Active |
| HealthCCS | 3.0.0 | FDA UDI | Class II | Unknown |
| HealthFLD | 1.0 | FDA UDI | Class II | Active |
| HealthCCSng | 2.0 | FDA UDI | Class II | Active |
| HealthVCF | 1.0 | FDA UDI | Class II | Unknown |
| HealthPPT | 1.0 | FDA UDI | Class II | Active |
| HealthPNX | 2.0.0 | FDA UDI | Class II | Active |
| HealthPNX | 1.0.6 | FDA UDI | Class II | Active |
| HealthOST | 1.1 | FDA UDI | Class II | Active |
| HealthICH | 3.0.0 | FDA UDI | Class II | Active |
| HealthICH | 2.0.5 | FDA UDI | Class II | Active |
| HealthCCSng | 1.0 | FDA UDI | Class II | Active |
| HealthOST | K213944 | FDA 510(k) | Class II | Active |
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