Skip to content

BSD3543W

by BONTECH Co., Ltd.

510(k) K200787

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

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK200787 Date23 Apr 2020ClearedStatusActive

Official records

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  • Withdrawn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

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

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.

The BSD3543W is a Solid State X-Ray Imager (Flat Panel/Digital Imager), a Class II medical device designed for capturing high-resolution radiographic images. It employs digital technology to convert X-ray exposure into electronic signals, enabling real-time imaging for diagnostic radiology procedures. This imager is engineered to provide precise, high-quality visualisation of internal structures, supporting accurate medical assessments in clinical settings.

This device is intended for use in radiology departments and is supplied as a reusable medical instrument. It is cleared under FDA 510(k) regulation 892.1680 with a Substantially Equivalent (SESE) determination, authorised under K-number K200787. The BSD3543W operates within standard MRI safety guidelines for Class II devices and requires proper maintenance and calibration to ensure optimal performance. It is not single-use and must be cleaned and sterilised according to established protocols.

Devices cleared under K200787

2 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K200787
UDI-DISize and differences
BSD3543W Digital Flat Panel X-ray Detector BT-DA22W
Bontech, Inc.
BT-DA22W08800069500051 —On the market
BSD3543W Digital Flat Panel X-ray Detector BT-DB22W
Bontech, Inc.
BT-DB22W08800069500068 —On the market

Similar devices

Other devices filed under FDA product code MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager)).

Other devices from BONTECH Co., Ltd.

  • BONX805

    Class II

  • Bt-DB22W

    Class IIa