EXTRON 3; EXTRON 5; EXTRON 7— 510(k) K250010

Name: FDA 510(k) clearance K250010
Creator: U.S. Food and Drug Administration
Published: 2025-06-10

Substantially Equivalent

DRTECH Corporation

FDA 510(k) clearance K250010 for EXTRON 3; EXTRON 5; EXTRON 7, Substantially Equivalent on 2025-06-10. Applicant: DRTECH Corporation. Device class: 2.

Clearance details

Applicant: DRTECH Corporation
Product code: Code OWB
Device class: Class 2
Regulation: 21 CFR 892.1650
Advisory panel: Radiology
Date received: 2025-01-02
Decision date: 2025-06-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seongnam-Si, KR

Download summary PDF View on FDA.gov ↗

Recent devices under product code OWB

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K253726 — uAngio AVIVA CX2026-08-21
K261413 — EXTRON 3; EXTRON 62026-08-19
K254205 — Zenition 302026-08-07
K260607 — Shield System (Siemens 30x40)2026-07-31
K253670 — SmartCT (R3.0 (L10))2026-07-10

More clearances from DRTECH Corporation

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K242770 — EXPD 114; EXPD 114G; EXPD 114P; EXPD 114PG2025-03-20
K243443 — EXPD 4343N1 +9 more2025-03-19
K242591 — XERO-alpha2024-11-01
K242847 — EXSYS DEXi (14 models)2024-10-23
K240243 — EConsole22024-09-23

Adverse events under product code OWB

product code OWB

Death: 49
Injury: 340
Malfunction: 36,973
Total: 37,362

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.