The following data is part of a premarket notification filed by Genoray America Inc. with the FDA for Zen-7000, Fluoroscopic X-ray System.
| Device ID | K103425 |
| 510k Number | K103425 |
| Device Name: | ZEN-7000, FLUOROSCOPIC X-RAY SYSTEM |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | GENORAY AMERICA INC. 1073 N. Batavia St Orange, CA 92867 |
| Contact | Jae Kim |
| Correspondent | Jae Kim GENORAY AMERICA INC. 1073 N. Batavia St Orange, CA 92867 |
| 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 | 2010-11-22 |
| Decision Date | 2011-03-29 |
| Summary: | summary |