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Sign in to claim this brandAvenda Health, Inc.
US
Last updated May 23, 2026
What Avenda Health, Inc. makes
Avenda Health, Inc. develops MRI image interpretive software, including AI-driven tools for diagnostic analysis and treatment planning. Their portfolio includes specialized software for prostate cancer planning and a system integrating AI with medical imaging for diagnostic support.
The company’s devices are classified as Class II under FDA regulations and are listed via 510(k) clearances and the Unique Device Identifier (UDI) program. 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 Avenda Health, Inc. primarily manufacture?
Avenda Health, Inc. specializes in MRI image interpretive software, with a focus on AI-driven tools. Their portfolio includes diagnostic analysis software and specialized applications like the Avenda Health AI Prostate Cancer Planning Software, as well as an integrated system combining AI with medical imaging for clinical support.
Where is Avenda Health, Inc. based, and how does that affect its regulatory standing?
Avenda Health, Inc. is headquartered in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations, including classification under the agency’s risk-based system. The U.S. regulatory framework ensures that devices like their MRI interpretive software and AI tools undergo evaluation for safety and effectiveness before commercialization.
How are Avenda Health’s devices classified under FDA regulations, and why does this matter?
Avenda Health’s devices fall under Class II classification by the FDA, indicating a moderate level of risk that requires special controls to ensure safety and performance. This classification means their products—such as the Avenda Health Treatment System or AI-driven diagnostic tools—must comply with specific regulatory requirements, including pre-market submissions like 510(k) clearances, to demonstrate equivalence to legally marketed predicate devices.
Which regulatory registries or databases list Avenda Health’s medical devices?
Avenda Health’s devices are listed in the FDA’s 510(k) clearance database and the Unique Device Identifier (UDI) program. These registries ensure transparency in device tracking, compliance verification, and post-market surveillance. The UDI system, for example, assigns a standardized identifier to each device variant, aiding in recall tracking and regulatory oversight.
How does Avenda Health’s focus on AI-driven software impact its regulatory pathway?
Since Avenda Health’s devices incorporate AI for MRI image interpretation and treatment planning, they must demonstrate both technical performance and clinical safety. The FDA evaluates these software tools under Class II regulations, requiring validation of algorithms, data integrity, and compliance with software development lifecycle (SDL) best practices. Clearances like the 510(k) ensure the AI tools meet established benchmarks for accuracy and reliability in their intended clinical use.
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
- 102268407
Catalogue (11)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Unfold AI | v0.6.0 | FDA UDI | Class II | Active |
| Unfold AI | v0.4.0 | FDA UDI | Class II | Active |
| Unfold AI | v0.3.0 | FDA UDI | Class II | Active |
| Unfold AI | v0.9.0 | FDA UDI | Class II | Active |
| Unfold AI | V0.1.4 | FDA UDI | Class II | Active |
| iQuest | V0.1.4 | FDA UDI | Class II | Active |
| Unfold AI | v0.8.0 | FDA UDI | Class II | Active |
| Unfold AI | v0.7.0 | FDA UDI | Class II | Active |
| Unfold AI | v0.5.0 | FDA UDI | Class II | Active |
| Avenda Health Treatment System | K201687 | FDA 510(k) | Class II | Active |
| Avenda Health AI Prostate Cancer Planning Software | K221624 | FDA 510(k) | Class II | Active |
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