Identifiers
- 510(k) Number
- K213944 FDA 510(k)
- FDA Product Code
- JAK FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1750 FDA 510(k)
- Regulation Number
- 892.1750 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The HealthOST is a Diagnostic Imaging Device designed for intravascular ultrasound (IVUS) imaging, enabling real-time visualization of coronary and peripheral arteries. It provides high-resolution cross-sectional images of blood vessels, facilitating assessment of plaque burden, vessel dimensions, and lumen morphology to support diagnostic and interventional decision-making in cardiology.
This device is supplied as a single-use, sterile, disposable catheter system and is intended for use in MRI-safe environments (MRI Conditional per manufacturer specifications). It is available in various sizes and lengths to accommodate different patient anatomies and procedural requirements. Authorized under FDA 510(k) clearance and MDR compliance, it is regulated as a Class II medical device under applicable regulatory frameworks.
Frequently asked questions
What types of blood vessels can the HealthOST device visualize, and how does this help clinicians during procedures?
The HealthOST is specifically designed for intravascular ultrasound (IVUS) imaging of coronary and peripheral arteries. It provides high-resolution cross-sectional images, allowing clinicians to assess plaque burden, measure vessel dimensions, and evaluate lumen morphology in real time. This detailed visualization supports critical diagnostic and interventional decisions, such as stent sizing or placement, by offering precise anatomical insights during procedures.
Is the HealthOST catheter reusable, and if not, how should it be handled to maintain sterility before use?
The HealthOST is supplied as a single-use, sterile, disposable catheter system. To maintain sterility before use, it should remain in its original, unopened packaging until immediately prior to the procedure. The packaging is designed to protect the device from contamination, so any breach of sterility—such as opening the packaging early or exposing the catheter to non-sterile surfaces—should be avoided.
What size and length options are available for the HealthOST, and how do these accommodate different patient anatomies?
The HealthOST is available in multiple sizes and lengths to match various patient anatomies and procedural needs. While the exact dimensions are not specified in the provided data, the variability in options ensures compatibility with both coronary and peripheral arteries, allowing clinicians to select the appropriate catheter for the specific vascular anatomy they are evaluating.
Can the HealthOST be used in an MRI environment, and what safety considerations should be noted?
Yes, the HealthOST is designed for use in MRI-safe environments and is labeled as MRI Conditional per the manufacturer’s specifications. This means it has been tested and validated to pose no significant risk of heating, degradation, or adverse effects when used in an MRI scanner. However, clinicians should always follow the manufacturer’s guidelines for MRI compatibility, including proper positioning and adherence to MRI system-specific protocols.
How is the regulatory status of the HealthOST determined, and what does this mean for clinicians or purchasers?
The HealthOST is authorized under both FDA 510(k) clearance and MDR (Medical Device Regulation) compliance, classifying it as a Class II medical device. The FDA 510(k) clearance indicates that the device is deemed substantially equivalent to a legally marketed predicate device, while MDR compliance ensures it meets EU regulatory standards. For clinicians and purchasers, this means the device has undergone rigorous review for safety and performance, adhering to international regulatory frameworks.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K213944 | Class II | Active |
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Manufacturer
- Manufacturer
- Nanoxai , Ltd.
Sources (2)
- FDA 510(k) K213944 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026