Cleared Traditional

K160204 - BSD4343 Digital Flat Panel X-ray Detector

K160204 is an FDA 510(k) clearance for BSD4343 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 Traditional 510(k) pathway after a 133-day FDA review.

K160204 · Bontech, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2016
Decision
133d
Days
Class 2
Risk

K160204 is an FDA 510(k) clearance for the BSD4343 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 9, 2016 after a review of 133 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1680 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K160204

510(k) Number K160204 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 2016
Decision Date June 09, 2016
Days to Decision 133 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d slower than avg
Panel avg: 107d · This submission: 133d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Consultant

Mtechgroup
Dave Kim

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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

All 423
Devices cleared under the same product code (MQB) and FDA review panel - the closest regulatory comparables to K160204.
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