K211780 is an FDA 510(k) clearance for the ZEN-2090 Turbo. This device is classified as a Interventional Fluoroscopic X-ray System (Class II - Special Controls, product code OWB).
Submitted by Genoray Co., Ltd. (Seongnam-Si, KR). The FDA issued a Cleared decision on March 9, 2022, 273 days after receiving the submission on June 9, 2021.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1650. Interventional Fluoroscopy.
| 510(k) Number | K211780 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 09, 2021 |
| Decision Date | March 09, 2022 |
| Days to Decision | 273 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | OWB — Interventional Fluoroscopic X-ray System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1650 |
| Definition | Interventional Fluoroscopy |