The following data is part of a premarket notification filed by Gemss Medical Systems Co., Ltd with the FDA for Spinel 12hd Interventional Fluoroscopic Mobile X-ray System.
| Device ID | K163140 |
| 510k Number | K163140 |
| Device Name: | SPINEL 12HD Interventional Fluoroscopic Mobile X-ray System |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | GEMSS MEDICAL SYSTEMS CO., LTD 2nd Floor, 29, Dunchon-daero 541 Beon-gil, Jungwon-gu Seongnam-si, KR 13216 |
| Contact | Sang Woo Lee |
| Correspondent | Dave Kim Mtech Group 8310 Buffalo Speedway Houston, TX 77025 |
| 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 | 2016-11-09 |
| Decision Date | 2017-05-26 |
| Summary: | summary |