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Shimadzu Surgical Mobile C-Arm Imaging X-Ray System, Model WHA-200

FDA 510(k)

Class II (US FDA 510(k))

510(k) K043379

by Shimadzu Corp.

Identifiers

510(k) Number
K043379 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 Shimadzu Surgical Mobile C-Arm Imaging X-Ray System, Model WHA-200, is a mobile, image-intensified fluoroscopic X-ray system designed for intraoperative imaging. It provides real-time radiographic visualization to support surgical procedures, enabling precise guidance and assessment during interventions.

This system is intended for use in surgical and emergency settings, offering portability for intraoperative imaging without requiring fixed infrastructure. Supplied as a reusable medical device, it is regulated under FDA 510(k) clearance (K043379) and classified as a Class II device. Compliance with regulatory standards ensures safe and reliable performance in clinical environments.

Frequently asked questions

Is the Shimadzu Surgical Mobile C-Arm Imaging X-Ray System designed for single-use or reusable applications in the operating room?

The Shimadzu Surgical Mobile C-Arm Imaging X-Ray System, Model WHA-200, is explicitly supplied as a reusable medical device. This means it is intended for repeated use in surgical and emergency settings after proper cleaning, disinfection, and maintenance procedures. Reusability is a key feature for reducing waste and ensuring cost-effective intraoperative imaging.

What types of surgical settings is this mobile C-arm system intended for, and why is portability important?

The system is designed for intraoperative imaging in surgical and emergency settings, where real-time radiographic visualization is critical. Its portability eliminates the need for fixed infrastructure, allowing it to be moved easily between operating rooms, trauma bays, or other clinical areas where imaging guidance is required during procedures. This flexibility supports procedures where traditional fixed fluoroscopy systems may not be practical.

How is the regulatory status of this device determined, and what does the FDA clearance number indicate?

The device holds FDA 510(k) clearance (K043379), meaning it was determined to be substantially equivalent to a legally marketed predicate device through an abbreviated review process. The clearance was granted under the Radiology (RA) advisory committee and classified as a Class II device, indicating it carries moderate risk and requires compliance with regulatory standards to ensure safe and effective performance in clinical environments.

Are there specific model variations or configurations for the WHA-200, or is it a single unified system?

The data provided does not specify multiple model variations for the WHA-200, implying it is a single unified system designed for intraoperative imaging. However, the OpenFDA registration numbers suggest it may have been distributed across multiple facilities or configurations under the same model designation. For precise technical specifications (e.g., image resolution, weight, or arm configurations), consulting the manufacturer’s technical documentation would be necessary.

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: Mobile C-arm - SHIMADZU CORPORATION, Mobile C-arm / with video column WHA-200 OPESCOPE ACTIVO Shimadzu, Shimadzu Surgical Mobile C-Arm Imaging X-Ray Wha-200, Shimadzu WHA-200 OPESCOPE ACTIVO C-Arm - Manufacturer specifications

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Shimadzu Corp.

Sources (1)

  • FDA 510(k) K043379 24 fields · synced Sep 19, 2026