Cleared Special

K223124 - EXPD 86P, EXPD 86PG, EXPD 129P, EXPD 129PG

K223124 is an FDA 510(k) clearance for EXPD 86P, 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 46-day FDA review.

K223124 · DRTECH Corporation · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2022
Decision
46d
Days
Class 2
Risk

K223124 is an FDA 510(k) clearance for the EXPD 86P, EXPD 86PG, EXPD 129P, EXPD 129PG. Classified as Solid State X-ray Imager (flat Panel/digital Imager) (product code MQB), Class II - Special Controls.

Submitted by DRTECH Corporation (Jungwon-Gu, Seongnam-Si, KR). The FDA issued a Cleared decision on November 18, 2022 after a review of 46 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.

FDA 510(k) Submission Details - K223124

510(k) Number K223124 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 2022
Decision Date November 18, 2022
Days to Decision 46 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
61d faster than avg
Panel avg: 107d · This submission: 46d
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
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K223124 · EXPD 86P, EXPD 86PG, EXPD 129P, EXPD 129PG
Download PDF FDA Summary DRTECH Corporation