# BSD3543W

> Active: United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/bsd3543w-mqb>
- Manufacturer: [BONTECH Co., Ltd.](https://devicerts.com/manufacturers/bontech-co-ltd) (South Korea)
- Device class: Class II (US FDA)
- FDA product code: MQB

## Overview

*AI-generated summary, 2026-10-01. Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data 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.

## Registrations and authorizations

- **510(k)** · FDA 510(k) · United States · K200787 · decision 2020-04-23 · decision SESE · status: Active

## Recalls

No recall on record.

## Identifiers

- 510(k) Number: K200787 [FDA 510(k)]
- FDA product code: MQB [FDA 510(k)]

## Classification

- Device class: Class II [FDA 510(k)]
- Regulation: 21 CFR Part 892.1680 [FDA 510(k)]
- Advisory committee: Radiology [FDA 510(k)]
- FDA decision: SESE [FDA 510(k)]

## Source and citation

- Cite as: BSD3543W, BONTECH Co., Ltd. deviCERTS medical device catalogue. https://devicerts.com/devices/bsd3543w-mqb (data as of 2026-11-15).
- Data sources: [FDA 510(k)](https://open.fda.gov/apis/device/510k/)
- Registry records last synced: 2026-10-22
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/bsd3543w-mqb.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/bsd3543w-mqb
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.