The Garion is intended to be used and operated by: adequately trained, qualified and authorized health care professionals who have full understanding of the safety information and emergency…
The Garion is intended to be used and operated by: adequately trained, qualified and authorized health care professionals who have full understanding of the safety information and emergency procedures as well as the capabilities and functions of the device. The device is used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except neonates (birth to one month), within the limits of the device. The device is to be used in health care facilities both inside and outside the operating room, sterile as well as non-sterile environment in a variety of procedures.
Who Else Makes It
Concentrated in Beijing (2), Shanghai (2), Guangdong (1).
Record
Regulatory record for SG Healthcare | Listed by | SG Healthcare Co Ltd, South Korea |
| FDA product code | OWB |
| Device type | Interventional Fluoroscopic X-Ray System |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1650 |
| Establishment | Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K222080 |
| Record published | 2026-04-24 |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.