Submission Details
| 510(k) Number | K230871 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 30, 2023 |
| Decision Date | August 17, 2023 |
| Days to Decision | 140 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
Cleared
Traditional
EXTRON 5; EXTRON 7
Aug 2023
Decision
140d
Days
Class 2
Risk
About This 510(k) Submission
K230871 is an FDA 510(k) clearance for the 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 August 17, 2023, 140 days after receiving the submission on March 30, 2023. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1650.
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 |
Manufacturer
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