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Flat Panel Detector

by Iray Technology Taicang, Ltd.

510(k) K221714

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK221714 Date29 Jun 2022ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
MQB
FDA applicant
Iray Technology Taicang , Ltd.
Device Class
Class II
Regulation
21 CFR Part 892.1680
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Flat Panel Detector is a solid-state X-ray imager designed for general radiographic diagnosis. It captures X-ray images digitally using a flat panel sensor, providing immediate image output for diagnostic evaluation. The device is intended for use in medical imaging settings where digital radiography is required.

This single-use, sterile device is supplied ready for clinical deployment and is not designed for reuse. It operates without MRI compatibility claims and is stored in a controlled environment prior to use. The device is regulated under FDA 510(k) clearance with substantial equivalence determination, and its use is limited to the indications described in its regulatory submission.

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Questions

AI-generated answers, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Flat Panel Detector used for?

    It is a solid-state X-ray imager designed for general radiographic diagnosis. The device captures X-ray images digitally using a flat panel sensor, providing immediate image output for diagnostic evaluation in medical imaging settings.

  • How is the Flat Panel Detector supplied?

    It is supplied as a single-use, sterile device ready for clinical deployment. The device is not designed for reuse and is stored in a controlled environment prior to use to maintain sterility and integrity.

  • Is the Flat Panel Detector MRI compatible?

    No, the device does not carry any MRI compatibility claims. It is intended solely for use in standard radiographic imaging environments and should not be used in or near MRI systems unless explicitly stated otherwise.

  • What is the regulatory status of this device?

    The Flat Panel Detector is regulated under FDA 510(k) clearance with a substantial equivalence determination. It was cleared under K221714 and is classified under product code MQB as a Class II device.

  • What storage conditions are required for this device?

    The device must be stored in a controlled environment prior to use. Specific temperature and humidity ranges are not detailed in the available data, but controlled storage is necessary to preserve sterility and electronic integrity before clinical deployment.