Axial3D Insight
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Axial3D Insight EUDAMED
- Device Name
- Axial3D Insight EUDAMED
- Model / Reference
- RCPXXXXX EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05065007075012 EUDAMED
- Basic UDI-DI
- 5065007075012T7 EUDAMED
- 510(k) Number
- K250369 FDA 510(k)
- FDA Product Code
- QIH FDA 510(k)
- EMDN Code
- V92 MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES EUDAMED
Classification
- Device Class
- Class I EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.2050 FDA 510(k)
- Regulation Number
- 892.2050 FDA 510(k)
- Special Device Type
- Software EUDAMED
- Market of Registration
- Northern Ireland EUDAMED
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
The Axial3D Insight is a 3D medical imaging system designed for advanced volumetric imaging of anatomical structures. It provides high-resolution, cross-sectional imaging to support diagnostic and treatment planning in radiology, leveraging axial and multiplanar reconstruction capabilities for detailed visualization.
This device is intended for use in radiology departments and clinical imaging settings, supplied as a reusable medical imaging system. It is regulated under FDA 510K clearance and MDR compliance, with a product code classification of QIH. The system requires proper installation, calibration, and maintenance in controlled environments to ensure accurate imaging performance.
Frequently asked questions
What types of anatomical structures can the Axial3D Insight visualize, and how does its imaging help in clinical settings?
The Axial3D Insight is designed for volumetric imaging of anatomical structures, providing high-resolution, cross-sectional views through axial and multiplanar reconstruction. This capability supports diagnostic evaluations and treatment planning in radiology by offering detailed visualization of internal structures, aiding clinicians in assessing complex cases with precision.
Is the Axial3D Insight intended for single-use or repeated use in clinical environments, and what maintenance is required?
The Axial3D Insight is supplied as a reusable medical imaging system, meaning it is built for long-term use in radiology departments. To ensure accurate performance, it requires proper installation, calibration, and routine maintenance in controlled environments—standard for high-end imaging equipment.
How is the regulatory status of the Axial3D Insight determined, and which governing bodies have approved it?
The Axial3D Insight holds FDA 510(k) clearance and complies with MDR (Medical Device Regulation) standards. Its classification under product code QIH (Radiology) and clearance via the Radiology (RA) Advisory Committee confirms its intended use in imaging applications, ensuring it meets stringent regulatory requirements for diagnostic devices.
What should clinicians consider when storing or handling the Axial3D Insight to maintain its performance?
Since the Axial3D Insight is a reusable imaging system, it must be stored in a controlled environment to protect its components from damage or contamination. Proper calibration and maintenance protocols—outlined in the manufacturer’s guidelines—must be followed to preserve imaging accuracy and longevity, as with all high-end medical imaging equipment.
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 | K250369 | Class II | Active |
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Manufacturer
- Manufacturer
- Axial Medical Printing Limited
Sources (2)
- FDA 510(k) K250369 24 fields · synced Sep 18, 2026
- EUDAMED 46f090ae-e42a-4df5-b7b8-ce8a9ac9d766 61 fields · synced Jul 11, 2026