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Exposcop Mobile Imaging System

by Euro-Electronics, Inc. 510(k)

Active United States

510(k) K851031

Overview

The Exposcop Mobile Imaging System is a Class II fluoroscopic X-ray imaging device, specifically an image-intensified mobile C-arm system. It is designed for real-time radiographic visualization, enabling dynamic imaging of internal structures during procedures such as orthopedic surgeries, fluoroscopically guided interventions, or diagnostic evaluations in radiology settings.

This system is intended for use in clinical radiology departments and mobile imaging applications, where portability is advantageous. Supplied as a reusable medical device, it requires proper maintenance and calibration to ensure accurate imaging. The Exposcop Mobile Imaging System holds an FDA 510(k) clearance under K-number K851031, with regulatory classification under the product code JAA and regulation number 892.1650. It is not specified as MRI-safe or single-use, and storage conditions align with standard medical imaging equipment protocols.

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK851031 Date28 May 1985ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

1 recall · FDA

    • Terminated Z-0562-2014 FDA Class II initiated 21 Nov 2013 via K851031, on the same 510(k)

    Engineering change in 2006 resulted in a minor non-conformity of their devices. Specifically the emergency switch was changed from a standard component to just an option on the devices.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

Specification

510(k)

510(k) Number
FDA Product Code
JAA
Device Class
Class II
Regulation
21 CFR Part 892.1650
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Questions

  • What is the Exposcop Mobile Imaging System used for?

    The Exposcop Mobile Imaging System is a Class II fluoroscopic X-ray device designed for real-time radiographic visualization. It enables dynamic imaging of internal structures during procedures such as orthopedic surgeries, fluoroscopically guided interventions, or diagnostic evaluations in radiology settings. Its portability makes it ideal for mobile applications where flexibility is needed.

  • Is the Exposcop Mobile Imaging System reusable or single-use?

    The Exposcop Mobile Imaging System is supplied as a reusable medical device. Like all reusable equipment, it requires proper maintenance, calibration, and cleaning to ensure accurate imaging and compliance with clinical standards. Regular servicing is essential to sustain performance and safety.

  • What regulatory clearance does the Exposcop Mobile Imaging System hold?

    The Exposcop Mobile Imaging System holds FDA 510(k) clearance under the K-number K851031. This clearance indicates that the device has been determined to be substantially equivalent to a legally marketed predicate device, meeting regulatory requirements for safety and effectiveness in its intended use.

  • How should the Exposcop Mobile Imaging System be stored?

    The Exposcop Mobile Imaging System should be stored according to standard protocols for medical imaging equipment. This includes keeping it in a clean, dry environment, protected from physical damage, and ensuring all components are securely fastened. Proper storage conditions help maintain functionality and longevity of the device.

  • What are the key specifications or features that distinguish this system?

    The Exposcop Mobile Imaging System is an image-intensified mobile C-arm fluoroscopy device, designed for portability and real-time imaging. It is classified under product code JAA and regulation number 892.1650, with a long history of use in radiology. The system is not specified as MRI-safe and requires regular maintenance to ensure accurate and reliable performance.