EXTRON 3; EXTRON 6— 510(k) K261413
Substantially EquivalentDRTECH Corporation
FDA 510(k) clearance K261413 for EXTRON 3; EXTRON 6, Substantially Equivalent on 2026-08-19. Applicant: DRTECH Corporation. Device class: 2.
Summary
DRTECH's submission lists the EXTRON 3 and EXTRON 6, filed under product code OWB, interventional fluoroscopic x-ray systems. The record doesn't say how the two differ.
Class II, 21 CFR 892.1650. Radiology is both the classification panel and the review panel. It came in as a Traditional 510(k).
DRTECH filed from Seongnam-Si, South Korea. The decision came 111 calendar days after receipt (April 30 to August 19, 2026), and it was substantially equivalent.
Clearance details
- Device name as filed
- EXTRON 3;EXTRON 6
- Applicant
- DRTECH Corporation
- Product code
- Product code OWB
- Device class
- Class 2
- Regulation
- 21 CFR 892.1650
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Seongnam-Si, KR
Recent devices under product code OWB
view allMore clearances from DRTECH Corporation
view allAdverse events under product code OWB
product code OWB- Death
- 49
- Injury
- 340
- Malfunction
- 36,973
- Total
- 37,362
Source: openFDA MAUDE database, through . 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.