Cleared Traditional

EXTRON 3; EXTRON 5; EXTRON 7

K250010 · DRTECH Corporation · Radiology
Jun 2025
Decision
159d
Days
Class 2
Risk

About This 510(k) Submission

K250010 is an FDA 510(k) clearance for the EXTRON 3; EXTRON 5; EXTRON 7, a Interventional Fluoroscopic X-ray System (Class II — Special Controls, product code OWB), submitted by DRTECH Corporation (Seongnam-Si, KR). The FDA issued a Cleared decision on June 10, 2025, 159 days after receiving the submission on January 2, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1650.

Submission Details

510(k) Number K250010 FDA.gov
FDA Decision Cleared SESE
Date Received January 02, 2025
Decision Date June 10, 2025
Days to Decision 159 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code OWB — Interventional Fluoroscopic X-ray System
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1650
Definition Interventional Fluoroscopy

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