ProxiDiagnost N90 / Precision CRF (706110, 706400)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K233945 FDA 510(k)
- FDA Product Code
- JAA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1650 FDA 510(k)
- Regulation Number
- 892.1650 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The ProxiDiagnost N90 / Precision CRF (706110, 706400) is an X-Ray, Fluoroscopic, Image-Intensified System designed for radiography and fluoroscopy procedures. It integrates advanced imaging capabilities to support a wide range of diagnostic exams, including chest, spine, extremity, and vascular studies such as Digital Subtraction Angiography (DSA).
This device is intended for use in radiology departments and is supplied as a reusable medical system. It operates under FDA 510(k) clearance and MDD authorization, adhering to regulatory standards for Class 2 radiation-emitting products. The system is not single-use and requires proper maintenance, calibration, and storage in accordance with manufacturer guidelines to ensure MRI safety and performance integrity.
Frequently asked questions
What types of medical imaging procedures can the ProxiDiagnost N90 / Precision CRF support, and how does it differ from standard X-ray systems?
The ProxiDiagnost N90 / Precision CRF is designed for both radiography and fluoroscopy, enabling a wide range of diagnostic exams including chest, spine, extremity, and vascular studies such as Digital Subtraction Angiography (DSA). Unlike standard X-ray systems, it integrates advanced imaging capabilities through fluoroscopy and image intensification, allowing real-time visualization and dynamic imaging during procedures. This makes it particularly useful for interventional radiology and complex diagnostic evaluations.
Is the ProxiDiagnost N90 / Precision CRF a single-use device, or is it intended for repeated use in a clinical setting?
The ProxiDiagnost N90 / Precision CRF is explicitly described as a reusable medical system. It requires proper maintenance, calibration, and storage to ensure performance integrity and MRI safety, as outlined by the manufacturer. This makes it suitable for long-term use in radiology departments rather than single-use applications.
What regulatory pathways has the ProxiDiagnost N90 / Precision CRF followed, and what does this mean for its use in clinical practice?
The device has obtained FDA 510(k) clearance and MDD authorization, confirming compliance with regulatory standards for Class 2 radiation-emitting products. This means it has undergone evaluation to demonstrate substantial equivalence to predicate devices and adheres to safety and performance requirements for fluoroscopic imaging systems. Clinicians can rely on its regulatory approval for use in radiology departments.
How should the ProxiDiagnost N90 / Precision CRF be stored to maintain its performance and safety?
The manufacturer specifies that the device requires proper maintenance, calibration, and storage to ensure performance integrity and MRI safety. While exact storage conditions aren’t detailed, typical guidelines for reusable fluoroscopic systems—such as protection from physical damage, environmental contaminants, and adherence to electromagnetic interference (EMI) precautions—should be followed. Always refer to the manufacturer’s instructions for precise storage protocols.
What types of diagnostic exams are most commonly performed using this device, and why is it well-suited for those procedures?
The ProxiDiagnost N90 / Precision CRF is particularly well-suited for chest, spine, extremity, and vascular studies, including Digital Subtraction Angiography (DSA). Its fluoroscopic and image-intensified capabilities allow for real-time imaging, which is critical during interventional procedures like angiography, where precise visualization of blood vessels and contrast flow is essential. This makes it ideal for both diagnostic and therapeutic radiology applications.
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. Sources consulted: Class 2 Device Recall ProxiDiagnost N90 / Precision CRF (706110, 706400, ProxiDiagnost N90 - Philips, ProxiDiagnost N90 / Precision CRF (706110, 706400) (K233945) — FDA 510 ..., ProxiDiagnost N90 / Precision CRF (706110, 706400) (K233945) — FDA 510 ...
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K233945 | Class II | Active |
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Manufacturer
- Manufacturer
- Philips Medical Systems DMC GmbH
Sources (2)
- FDA 510(k) K233945 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026