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ANYVIEW-500R Fluoroscopic Mobile X-Ray System

by Ecotron Co., Ltd South Korea EUDAMED510(k)

510(k) K160279 Product code OWB

Overview

The Anyview-500R Fluoroscopic Mobile X-Ray System is an Interventional Fluoroscopic X-Ray System, designed for real-time imaging during medical procedures. It provides high-resolution fluoroscopic visualization to assist in guiding interventions such as orthopedic surgeries, vascular procedures, and other radiology-guided treatments.

This mobile system is intended for use in radiology departments and operating rooms, offering portability and flexibility for various clinical settings. Supplied as a reusable device, it requires adherence to standard sterilization protocols. The system is classified as Class II under FDA regulations and has received FDA 510K clearance (K160279) and MDD compliance. It is not MRI-safe and must be used in accordance with manufacturer guidelines for safe operation and maintenance.

Summary written by AI from registry data, 18 Sep 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically 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.

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK160279 Date14 Oct 2016ClearedStatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive

Coverage

2 jurisdictions

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 AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDD Expiring
  • United States FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · 510(k) · synced 22 Oct 2026

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

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Questions

  • What is the Anyview-500R Fluoroscopic Mobile X-Ray System used for?

    The Anyview-500R is an interventional fluoroscopic X-ray system designed for real-time imaging during medical procedures, including orthopedic surgeries, vascular procedures, and other radiology-guided treatments.

  • Is the Anyview-500R a single-use device?

    No, the Anyview-500R is supplied as a reusable device that requires adherence to standard sterilization protocols between uses.

  • What regulatory approvals does the Anyview-500R have?

    The Anyview-500R has received FDA 510K clearance (K160279) and MDD compliance, and is classified as Class II under FDA regulations.

  • Where can the Anyview-500R be used in a clinical setting?

    This mobile system is intended for use in radiology departments and operating rooms, offering portability and flexibility for various clinical settings.

  • Is the Anyview-500R MRI-safe?

    No, the Anyview-500R is not MRI-safe and must be used in accordance with manufacturer guidelines for safe operation and maintenance.

Properties & raw data

Show properties, registry sources and raw records

Sources (2)

  • FDA 510(k) K160279 24 fields · synced 22 Oct 2026
  • EUDAMED 1 fields · synced 19 May 2026