The following data is part of a premarket notification filed by Genoray Co., Ltd. with the FDA for Zen-2090 Turbo.
| Device ID | K211780 |
| 510k Number | K211780 |
| Device Name: | ZEN-2090 Turbo |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | Genoray Co., Ltd. 512, 560, Dunchon-daero, Jungwon-gu Seongnam-si, KR 13230 |
| Contact | Sookyung Choi |
| Correspondent | Kaitlynn Min Genoray America Inc. 147 E. Bristol Lane Orange, CA 92780 |
| Product Code | OWB |
| Subsequent Product Code | JAA |
| Subsequent Product Code | OXO |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-09 |
| Decision Date | 2022-03-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809244060120 | K211780 | 000 |