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MultiScan G-Arm System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K151280

by Beijing East Whale Imaging Technology Co., Ltd.

Identifiers

510(k) Number
K151280 FDA 510(k)
FDA Product Code
OXO 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 MultiScan G-Arm System is an Image-Intensified Fluoroscopic X-Ray System, Mobile, designed for real-time radiographic imaging. It combines fluoroscopy with image intensification to provide high-resolution, dynamic visualisation of internal anatomical structures during procedures. The system is equipped for biplanar imaging, enabling simultaneous views from two angles to enhance procedural accuracy and control.

This mobile device is intended for use in radiology settings, offering both single-use and reusable configurations based on component specifications. It operates under FDA 510(k) clearance (K151280) and adheres to regulatory standards for Class II medical devices. The system is not MRI-safe and requires proper storage and handling as per manufacturer guidelines. Multiple model references (e.g., 3013099020, 3027339477) denote variations in configuration or compliance with regional regulations.

Frequently asked questions

What is the MultiScan G-Arm System used for?

The MultiScan G-Arm System is an Image-Intensified Fluoroscopic X-Ray System designed for real-time radiographic imaging. It provides dynamic visualization of internal anatomical structures during procedures, particularly in radiology settings. The system’s biplanar imaging capability allows simultaneous views from two angles, enhancing accuracy and control during interventions like orthopedic surgeries, vascular procedures, or other fluoroscopy-dependent treatments.

How is the MultiScan G-Arm System supplied, and can components be reused?

The MultiScan G-Arm System is available in both single-use and reusable configurations, depending on the specific components included in the model. The manufacturer offers variations to accommodate different clinical workflows, ensuring flexibility for sterile procedures or routine use. Always refer to the model’s documentation or consult the manufacturer for guidance on component reuse, as this depends on the configuration and regional regulatory requirements.

What model references or variations exist for the MultiScan G-Arm System?

The MultiScan G-Arm System includes multiple model references, such as 3013099020, 3027339477, and others listed in the regulatory records. These variations may reflect differences in configuration, regional compliance, or specific clinical applications. The manufacturer tailors these models to meet diverse procedural needs while adhering to regulatory standards like FDA 510(k) clearance (K151280).

Is the MultiScan G-Arm System MRI-safe, and how should it be stored?

The MultiScan G-Arm System is explicitly not MRI-safe, meaning it should never be used or stored in an MRI environment. Proper storage involves following the manufacturer’s guidelines to maintain functionality, sterility (if applicable), and safety. This includes protecting the device from physical damage, extreme temperatures, and environmental contaminants, as well as ensuring components are securely stored when not in use.

What regulatory pathway does the MultiScan G-Arm System follow?

The MultiScan G-Arm System is classified as a Class II medical device under FDA regulations and has obtained FDA 510(k) clearance (K151280), demonstrating substantial equivalence to a predicate device. It also adheres to regulatory standards outlined in the regulation number 892.1650, ensuring compliance with safety and performance requirements for fluoroscopic imaging systems. Always verify the specific model’s regulatory documentation for regional variations.

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: MultiScan G-Arm System (K160984) — FDA 510 (k) | Innolitics, The G-Arm® Advantage - Whale Imaging, MultiScan G-Arm System — FDA 510 (k) K160984 | MedTracker

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Beijing East Whale Imaging Technology Co., Ltd.

Sources (1)

  • FDA 510(k) K151280 24 fields · synced Oct 1, 2026