K-number	K222080
Device name	Garion Image-Intensified Fluoroscopic X-Ray System, Mobile
Applicant	Sg Healthcare Co, Ltd.
Product code	OWB
Device class	Class II
Decision date	Oct 6, 2022
Decision	Substantially Equivalent
Regulation	892.1650

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View the full FDA submission: accessdata.fda.gov

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Garion Image-Intensified Fluoroscopic X-Ray System, Mobile

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