Cleared Special

K162487 - BSD3543 Digital Flat Panel X-ray Detector

K162487 is an FDA 510(k) clearance for BSD3543 Digital Flat Panel X-ray Detector, manufactured by Bontech, Inc.. The device is a Class 2 Radiology device with product code MQB cleared through the Special 510(k) pathway after a 37-day FDA review.

K162487 · Bontech, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2016
Decision
37d
Days
Class 2
Risk

K162487 is an FDA 510(k) clearance for the BSD3543 Digital Flat Panel X-ray Detector. Classified as Solid State X-ray Imager (flat Panel/digital Imager) (product code MQB), Class II - Special Controls.

Submitted by Bontech, Inc. (Suwon-Si, KR). The FDA issued a Cleared decision on October 14, 2016 after a review of 37 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1680 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Bontech, Inc. devices

FDA 510(k) Submission Details - K162487

510(k) Number K162487 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 2016
Decision Date October 14, 2016
Days to Decision 37 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 107d · This submission: 37d
Pathway characteristics
Modification to existing cleared device.

MQB Device Classification - Class 2, Special Controls

Product Code MQB Solid State X-ray Imager (flat Panel/digital Imager)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1680
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - MQB Solid State X-ray Imager (flat Panel/digital Imager)

All 283
Devices cleared under the same product code (MQB) and FDA review panel - the closest regulatory comparables to K162487.
VIVIX-S 1417N
K163703 · Vieworks Co., Ltd. · Feb 2017
EVS 4343, EVS 4343G
K162555 · DRTECH Corporation · Dec 2016
EVS 3643, EVS 3643G
K162552 · DRTECH Corporation · Dec 2016
1012WCC, 1012WGC
K162518 · Rayence Co., Ltd. · Oct 2016
1717WCC / 1717WGC
K162519 · Rayence Co., Ltd. · Oct 2016
SKR 3000
K162504 · Konica Minolta, Inc. · Oct 2016