The following data is part of a premarket notification filed by Genoray Co., Ltd. with the FDA for Zen-2090 Pro, Fluoroscopic X-ray System, Model Zen-2090 Pro.
| Device ID | K091918 |
| 510k Number | K091918 |
| Device Name: | ZEN-2090 PRO, FLUOROSCOPIC X-RAY SYSTEM, MODEL ZEN-2090 PRO |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | GENORAY CO., LTD. 215 S. STATE STREET, STE 100B Salt Lake City, UT 84111 |
| Contact | Shin Kuk Yoo |
| Correspondent | Shin Kuk Yoo GENORAY CO., LTD. 215 S. STATE STREET, STE 100B Salt Lake City, UT 84111 |
| 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 | 2009-06-30 |
| Decision Date | 2009-10-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809244060021 | K091918 | 000 |