Cleared Special

K232082 - EXPD 4343S

K232082 is an FDA 510(k) clearance for EXPD 4343S, manufactured by DRTECH Corporation. The device is a Class 2 Radiology device with product code MQB cleared through the Special 510(k) pathway after a 215-day FDA review.

K232082 · DRTECH Corporation · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2024
Decision
215d
Days
Class 2
Risk

K232082 is an FDA 510(k) clearance for the EXPD 4343S. Classified as Solid State X-ray Imager (flat Panel/digital Imager) (product code MQB), Class II - Special Controls.

Submitted by DRTECH Corporation (Gyeonggi-Do, KR). The FDA issued a Cleared decision on February 13, 2024 after a review of 215 days - an extended review 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K232082

510(k) Number K232082 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 2023
Decision Date February 13, 2024
Days to Decision 215 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
108d slower than avg
Panel avg: 107d · This submission: 215d
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 423
Devices cleared under the same product code (MQB) and FDA review panel - the closest regulatory comparables to K232082.
IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector)
K241346 · Aspen Imaging Healthcare, Inc. · Nov 2024
Digital Flat Panel X-ray Detector (1717WCE, 1717WCE-HR, 1717WCE-HS, 1717WCE-GF)
K242394 · Rayence Co., Ltd. · Sep 2024
0909FCC, 0909FCC-HS
K240371 · Rayence Co., Ltd. · Mar 2024
EXPD 4343D
K232753 · DRTECH Corporation · Nov 2023
MasterX 800 Series
K230918 · Medicatech USA · Sep 2023
YosemiteView 4343W/YosemiteView 3643W
K232058 · Careray Digital Medical Technology Co., Ltd. · Aug 2023
K232082 · EXPD 4343S
Download PDF FDA Summary DRTECH Corporation