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Sign in to claim this brandAclarion Inc
United States·US-MF-000042192
Last updated May 30, 2026
What Aclarion Inc makes
Aclarion Inc manufactures the NOCISCAN Suite, a diagnostic imaging system designed for non-invasive cardiac imaging, specifically for assessing coronary artery disease and myocardial perfusion. The system integrates advanced imaging algorithms to provide detailed visualizations of blood flow and cardiac function without the need for invasive procedures.
The NOCISCAN Suite is classified as a Class I medical device in the EU and is listed in the eudamed registry. 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 Aclarion Inc manufacture?
Aclarion Inc specializes in diagnostic imaging systems. Specifically, they develop the NOCISCAN Suite, a non-invasive cardiac imaging solution designed to evaluate coronary artery disease and myocardial perfusion. The system uses advanced imaging algorithms to visualize blood flow and cardiac function without requiring invasive procedures.
Where is Aclarion Inc based?
Aclarion Inc is headquartered in the United States. The company’s focus on developing diagnostic imaging technology is centered around this location.
Which regulatory registries list Aclarion Inc’s devices?
The NOCISCAN Suite is listed in the eudamed registry, which is the European database for medical devices. This registry tracks devices authorized for use within the European Union.
How are Aclarion Inc’s devices classified in the EU?
The NOCISCAN Suite falls under Class I classification in the EU. This classification is typically assigned to low-risk medical devices, such as diagnostic imaging systems with minimal risk to patients when used as intended.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- United States
- Address
- 8181 Arista Place, Broomfield, United States
- Website
- www.aclarion.com
- —
- —
- [email protected]
- Phone
- 6509546914
- PRRC Contact
- JOHN CLAUDE
- EUDAMED SRN
- US-MF-000042192
- FDA FEI Number
- —
- DUNS Number
- 963326157
Catalogue (2)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| NociCalc | NociCalc | FDA UDI | Class I | Unknown |
| NOCISCAN Suite | 200-00201 | EUDAMEDFDA UDI | Class I | Active |
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