The following data is part of a premarket notification filed by Genoray Co., Ltd. with the FDA for Zen-7000,system,fluroscopic X-ray System.
| Device ID | K140041 |
| 510k Number | K140041 |
| Device Name: | ZEN-7000,SYSTEM,FLUROSCOPIC X-RAY SYSTEM |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | GENORAY CO., LTD. 3002 DOW AVENUE SUITE 420 Tustin, CA 92780 |
| Contact | Kaitlynn Min |
| Correspondent | Kaitlynn Min GENORAY CO., LTD. 3002 DOW AVENUE SUITE 420 Tustin, 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 | 2014-01-08 |
| Decision Date | 2014-11-28 |
| Summary: | summary |