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Yushan X-Ray Flat Panel Detector

by InnoCare Optoelectronics Corp. Taiwan 510(k)

510(k) K250211 Product code MQB

Overview

The Yushan X-Ray Flat Panel Detector is a solid state X-ray imager designed for image acquisition. This device functions as a flat-panel digital imager that must be integrated with an operating PC and an X-ray generator to capture diagnostic images.

This device is authorized under FDA 510(k) clearance K250211. Federal law restricts this device to sale by or on the order of a radiologist or other licensed practitioner. Users should refer to the provided instruction manual for details on operation, battery charging, and storage requirements.

Summary written by AI from registry data, 25 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 Substantially Equivalent · Traditional NumberK250211 Date22 Jul 2025ClearedStatusActive

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

Specification

510(k) · synced 22 Oct 2026

510(k) Number
FDA Product Code
MQB
Device Class
Class II
Regulation
21 CFR Part 892.1680
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the primary function of the Yushan X-Ray Flat Panel Detector?

    This device functions as a solid state digital imager designed for the acquisition of diagnostic X-ray images. To operate, it must be integrated with an X-ray generator and an operating PC.

  • Who is authorized to purchase this device?

    Federal law restricts the sale of this device to or on the order of a radiologist or other licensed practitioner. This ensures the equipment is managed by qualified medical professionals.

  • Where can I find information regarding the operation and maintenance of this device?

    Users should refer to the provided instruction manual for all specific details regarding device operation, battery charging procedures, and storage requirements.

  • What is the regulatory status of this device?

    The Yushan X-Ray Flat Panel Detector is authorized under FDA 510(k) clearance K250211.

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K250211 24 fields · synced 22 Oct 2026