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Bsd3543w

FDA 510(k)

Class II (US FDA 510(k))

510(k) K200787

by BONTECH Co., Ltd.

Identifiers

510(k) Number
K200787 FDA 510(k)
FDA Product Code
MQB FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.1680 FDA 510(k)
Regulation Number
892.1680 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

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.

Frequently asked questions

What is the BSD3543W used for in medical imaging?

The BSD3543W is a solid-state X-ray imager designed specifically for capturing high-resolution radiographic images. It converts X-ray exposure into electronic signals, enabling real-time visualization of internal structures. This makes it ideal for diagnostic radiology procedures, where precise imaging is critical for accurate medical assessments in clinical settings like radiology departments.

Is the BSD3543W a single-use or reusable device?

The BSD3543W is a reusable medical device. As such, it must be cleaned and sterilized according to established protocols to maintain performance and ensure patient safety. Reusability also supports cost efficiency in clinical environments where frequent imaging is required.

What regulatory clearance does the BSD3543W hold?

The BSD3543W is cleared under the FDA’s 510(k) regulation, specifically under K-number K200787. It has a Substantially Equivalent (SESE) determination, meaning it meets the performance and safety criteria of a predicate device. This clearance ensures compliance with U.S. medical device regulations for diagnostic radiology use.

How should the BSD3543W be stored and maintained?

The BSD3543W requires proper maintenance and calibration to ensure optimal performance and image quality. Storage should follow manufacturer guidelines to protect the device from physical damage, moisture, or environmental contaminants. Regular servicing, as outlined in the device’s operational manual, is essential to sustain its functionality and longevity in clinical settings.

Does the BSD3543W comply with MRI safety guidelines?

Yes, the BSD3543W operates within standard MRI safety guidelines for Class II devices. This compliance ensures it can be safely used in environments where MRI procedures are performed, reducing the risk of interference or safety hazards. Always refer to the device’s documentation for specific safety protocols.

This description and any FAQs above were generated automatically from registry data 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. Sources consulted: Bontech Bsd3543w - allmed.wiki, Bontech Co., Ltd. FDA 510 (k) Products - Latest 2025, BSD3543W 510 (k) K200787 - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
BONTECH Co., Ltd.

Sources (1)

  • FDA 510(k) K200787 24 fields · synced Oct 1, 2026