BSD3543 Digital Flat Panel X-ray Detector
by Bontech, Inc. 510(k)
Active
510(k) K162487
Overview
The BSD3543 is a solid state X-ray imager designed to function as a digital flat panel detector. It operates by intercepting X-ray photons and using a scintillator to convert them into visible light, which is subsequently captured by an amorphous silicon TFT array to generate electrical signals for digital imaging.
This device is a Class II system that transmits digital values to an integrated PC and X-ray generator. It has received FDA 510(k) clearance under the regulation number 892.1680.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK162487 | Date14 Oct 2016 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 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
Other devices from Bontech, Inc.
Questions
What is the primary function of the BSD3543?
The BSD3543 is a solid state X-ray imager designed to function as a digital flat panel detector. It works by intercepting X-ray photons and using a scintillator to convert them into visible light, which is then captured by an amorphous silicon TFT array to produce electrical signals for digital imaging.
How does the device integrate with other equipment?
The system is designed to transmit digital values directly to an integrated PC and X-ray generator, allowing for the seamless capture and processing of radiographic data.
What is the regulatory classification of this detector?
The BSD3543 is classified as a Class II medical device. It has received FDA 510(k) clearance under regulation number 892.1680, which pertains to solid state X-ray imagers.