510(k) clearance
EXTRON 3;EXTRON 6
- 510(k) number
- K261413
- Applicant
- DRTECH Corporation
- Decision date
- Aug 19, 2026
- Date received
- Apr 30, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- OWB
- Device type
- Interventional Fluoroscopic X-Ray System
- Device class
- Class II
- Regulation
- 21 CFR 892.1650
- Advisory committee
- Radiology
- Statement or summary
- Summary
- Third party
- N
- Location
- Seongnam-Si, KR