Cleared Special

EXPD 4343N1; EXPD 4343N; EXPD 4343U1; EXPD 4343NU; EXPD 4343NP; EXPD 3643N1; EXPD 3643N; EXPD 3643U1; EXPD 3643NU; EXPD 3643NP

K243443 · DRTECH Corporation · Radiology
Mar 2025
Decision
133d
Days
Class 2
Risk

About This 510(k) Submission

K243443 is an FDA 510(k) clearance for the EXPD 4343N1; EXPD 4343N; EXPD 4343U1; EXPD 4343NU; EXPD 4343NP; EXPD 3643N1; EXPD 3643N; EXPD 3643U1; EXPD 3643NU; EXPD 3643NP, a Solid State X-ray Imager (flat Panel/digital Imager) (Class II — Special Controls, product code MQB), submitted by DRTECH Corporation (Gyeonggi-Do, KR). The FDA issued a Cleared decision on March 19, 2025, 133 days after receiving the submission on November 6, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1680.

Submission Details

510(k) Number K243443 FDA.gov
FDA Decision Cleared SESE
Date Received November 06, 2024
Decision Date March 19, 2025
Days to Decision 133 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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