Cleared Special

K171485 - BSD4343R Digital Flat Panel X-ray Detector

K171485 is an FDA 510(k) clearance for BSD4343R 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 30-day FDA review.

K171485 · Bontech, Inc. · Radiology device
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Jun 2017
Decision
30d
Days
Class 2
Risk

K171485 is an FDA 510(k) clearance for the BSD4343R 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 June 21, 2017 after a review of 30 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 - K171485

510(k) Number K171485 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 2017
Decision Date June 21, 2017
Days to Decision 30 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
77d faster than avg
Panel avg: 107d · This submission: 30d
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
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