Cleared Special

K232753 - EXPD 4343D

Also marketed or referenced as:
EXPD 3643D

K232753 is the FDA 510(k) clearance for EXPD 4343D by DRTECH Corporation. It is a Class 2 Radiology device (product code MQB) cleared through the Special 510(k) pathway after a 69-day FDA review.

K232753 · DRTECH Corporation · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2023
Decision
69d
Days
Class 2
Risk

K232753 is an FDA 510(k) clearance for the EXPD 4343D. Classified as Solid State X-ray Imager (flat Panel/digital Imager) (product code MQB), Class II - Special Controls.

Submitted by DRTECH Corporation (Seongnam-Si, KR). The FDA issued a Cleared decision on November 16, 2023 after a review of 69 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 DRTECH Corporation devices

Submission Details

510(k) Number K232753 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 2023
Decision Date November 16, 2023
Days to Decision 69 days
Submission Type Special
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
38d faster than avg
Panel avg: 107d · This submission: 69d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 218
Devices cleared under the same product code (MQB) and FDA review panel - the closest regulatory comparables to K232753.
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K242394 · Rayence Co., Ltd. · Sep 2024
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K231959 · DRTECH Corporation · Aug 2023