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FDA 510(k)

Garion Image-Intensified Fluoroscopic X-Ray System, Mobile

K-Number: K222080 · 2022-10-06

ApplicantSg Healthcare Co, Ltd.
Decision Date2022-10-06
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Garion Image-Intensified Fluoroscopic X-Ray System, Mobile is a medical device manufactured by Sg Healthcare Co, Ltd.. It received FDA 510(k) clearance on 2022-10-06 under approval number K222080. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Garion Image-Intensified Fluoroscopic X-Ray System, Mobile?

Garion Image-Intensified Fluoroscopic X-Ray System, Mobile is a medical device that received FDA 510(k) clearance on 2022-10-06. It is manufactured by Sg Healthcare Co, Ltd.. The 510(k) number is K222080.

When was Garion Image-Intensified Fluoroscopic X-Ray System, Mobile approved by the FDA?

Garion Image-Intensified Fluoroscopic X-Ray System, Mobile received FDA 510(k) clearance on 2022-10-06, under approval number K222080.

What company makes Garion Image-Intensified Fluoroscopic X-Ray System, Mobile?

Garion Image-Intensified Fluoroscopic X-Ray System, Mobile is manufactured by Sg Healthcare Co, Ltd..

What is the FDA product code for Garion Image-Intensified Fluoroscopic X-Ray System, Mobile?

The FDA product code for Garion Image-Intensified Fluoroscopic X-Ray System, Mobile is OWB.

Related Clinical Trials

NCT03288207 Tailoring Mobile Health Technology to Reduce Obesity and Improve Cardiovascular Health in Resource-Limited Neighborhood Environments RECRUITING NCT04981223 Predicting Location and Extent of Prostate Cancer Using Micro-Ultrasound Imaging COMPLETED NCT06385392 Continuous Wearable Monitor for the Detection and Release of Freezing of Gait. COMPLETED NCT04488224 Nano-X Image Guidance: CBCT With Gravity-induced Motion WITHDRAWN NCT06868979 Optical Imaging in X-linked Disorders. RECRUITING NCT07042620 A Study to Test a New Fluid to Improve the Quality of Images Obtained by Using Sound Waves (Ultrasound) During Surgery ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 39943397 Clinical Validation of a Video-Otoscopy-Based Medical Device for the Remote Diagnosis of Ear Complaints. Sensors (Basel, Switzerland) (2025)

Other Devices by Sg Healthcare Co, Ltd.

K230241Jumong General

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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