The following data is part of a premarket notification filed by Sg Healthcare Co Ltd with the FDA for Garion Image-intensified Fluoroscopic X-ray System, Mobile.
| Device ID | K222080 |
| 510k Number | K222080 |
| Device Name: | Garion Image-Intensified Fluoroscopic X-Ray System, Mobile |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | SG Healthcare CO LTD 10, Yangnyeong-ro, Yangpyeong-ri, Moga-myeon Seoul, KR 17408 |
| Contact | Byung Ju Kang |
| Correspondent | Daniel Kamm Kamm & Assosciates 8870 Ravello Ct Naples, FL 34114 |
| Product Code | OWB |
| Subsequent Product Code | IZI |
| Subsequent Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-07-15 |
| Decision Date | 2022-10-06 |