K181943 is an FDA 510(k) clearance for the OSCAR (OSCAR Prime, OSCAR Classic). 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 August 17, 2018, 28 days after receiving the submission on July 20, 2018.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1650. Interventional Fluoroscopy.
| 510(k) Number | K181943 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 20, 2018 |
| Decision Date | August 17, 2018 |
| Days to Decision | 28 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 |