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Aura DR 43C-AG flat panel detector

by Abyzr Co., Ltd.

510(k) K151014

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 · Traditional NumberK151014 Date13 Jul 2015ClearedStatusActive

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  • Withdrawn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
Device Class
Class II
Regulation
21 CFR Part 892.1680
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

Aura DR 43C-AG flat panel detector is a Solid State X-Ray Imager (Flat Panel/Digital Imager) used in radiology for digital imaging of human anatomy. It is designed to replace film or screen-based radiographic systems in general-purpose diagnostic procedures.

The device is supplied as a reusable component for general radiographic systems and has received FDA 510(k) clearance under K-number K151014, with a decision date of 2015-07-13. It is classified as a Class II medical device and is manufactured by Abyzr Co., Ltd. in Hwaseong-Si, Korea.

Questions

AI-generated answers, 1 Oct 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 Aura DR 43C-AG flat panel detector used for?

    The Aura DR 43C-AG flat panel detector is used in radiology for digital imaging of human anatomy, designed to replace film or screen-based radiographic systems in general-purpose diagnostic procedures.

  • Is the Aura DR 43C-AG flat panel detector reusable or single-use?

    The device is supplied as a reusable component for general radiographic systems, meaning it is intended for multiple uses after proper cleaning and maintenance, not as a single-use disposable.

  • What regulatory clearance does the Aura DR 43C-AG flat panel detector have?

    The device has received FDA 510(k) clearance under K-number K151014, with a decision date of 2015-07-13, and is classified as a Class II medical device.