Cleared Special

EXPD 114; EXPD 114G; EXPD 114P; EXPD 114PG

K242770 · DRTECH Corporation · Radiology
Mar 2025
Decision
188d
Days
Class 2
Risk

About This 510(k) Submission

K242770 is an FDA 510(k) clearance for the EXPD 114; EXPD 114G; EXPD 114P; EXPD 114PG, a Solid State X-ray Imager (flat Panel/digital Imager) (Class II — Special Controls, product code MQB), submitted by DRTECH Corporation (Jungwon-Gu, Seongnam-Si, KR). The FDA issued a Cleared decision on March 20, 2025, 188 days after receiving the submission on September 13, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1680.

Submission Details

510(k) Number K242770 FDA.gov
FDA Decision Cleared SESE
Date Received September 13, 2024
Decision Date March 20, 2025
Days to Decision 188 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code MQB — Solid State X-ray Imager (flat Panel/digital Imager)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1680

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