AnyView DR Series FPD Fluoroscopic Mobile C-Arm ANYVIEW-240DR, ANYVIEW-320DR, ANYVIEW-500DR
by Ecotron Co., Ltd EUDAMED510(k)
Active
510(k) K180473
Overview
The AnyView DR Series FPD Fluoroscopic Mobile C-Arm is classified as an Interventional Fluoroscopic X-Ray System, designed for real-time imaging during diagnostic and interventional procedures. It employs flat-panel detectors (FPD) to capture high-resolution fluoroscopic and spot film images, enabling precise visualization of anatomical structures and guidance for procedures such as orthopedics, cardiology, and vascular interventions.
This mobile C-arm system is intended for use in clinical settings such as emergency rooms, operating rooms, and interventional suites. Supplied as a reusable device, it requires adherence to standard sterilization protocols between uses. The system is not MRI-safe and is available in three configurations: ANYVIEW-240DR, ANYVIEW-320DR, and ANYVIEW-500DR, each distinguished by technical specifications. Authorized under FDA 510(k) clearance and MDD compliance, it is classified as a Class II medical device under regulatory frameworks.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK180473 | Date23 Mar 2018 | StatusActive |
| European Union | CE/MDD EUDAMED | Number— | Date— | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA Product Code
- OWB
- FDA applicant
- Ecotron Co., Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1650
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Ecotron Co., Ltd
Questions
What clinical settings is the AnyView DR Series FPD Fluoroscopic Mobile C-arm designed for, and how does its mobility benefit procedures?
The AnyView DR Series is specifically designed for real-time imaging in dynamic clinical environments like emergency rooms, operating rooms, and interventional suites. Its mobile C-arm design allows for easy repositioning around patients, enabling flexible use during procedures such as orthopedic surgeries, cardiology interventions, and vascular guidance. This mobility ensures the device can adapt to various patient positions and procedural needs without requiring the patient to move.
How are the different models (ANYVIEW-240DR, ANYVIEW-320DR, ANYVIEW-500DR) distinguished, and which one should I consider for high-resolution imaging?
The models are differentiated by their technical specifications, though the exact details are not provided in the data. Generally, the numerical suffix (e.g., 240DR, 320DR, 500DR) often correlates with resolution or detector size. For high-resolution imaging, the ANYVIEW-500DR is likely the most suitable due to its higher numerical designation, suggesting superior imaging capabilities for detailed anatomical visualization.
Is the AnyView DR Series FPD Fluoroscopic Mobile C-arm reusable, and what sterilization protocols should be followed between uses?
Yes, the AnyView DR Series is supplied as a reusable device. Since it is intended for use across multiple patients, it must adhere to standard sterilization protocols between procedures to ensure patient safety and device integrity. These protocols typically include cleaning with appropriate disinfectants followed by high-level disinfection or sterilization (e.g., autoclaving or chemical sterilization) as per manufacturer guidelines and facility policies.
What regulatory pathways has the AnyView DR Series undergone, and how does this affect its use in clinical practice?
The device has been authorized under FDA 510(k) clearance and complies with the Medical Device Directive (MDD), classifying it as a Class II medical device. This means it has undergone rigorous review by regulatory bodies to ensure safety and effectiveness for its intended use in interventional fluoroscopy. Clinicians can rely on this regulatory clearance to confirm the device meets established standards for real-time imaging during procedures like orthopedics, cardiology, and vascular interventions.