K-number	K232068
Device name	HyperLight Portable X-ray Unit
Applicant	Changzhou Sifary Medical Technology Co., Ltd.
Product code	EHD
Device class	Class II
Decision date	Sep 1, 2023
Decision	Substantially Equivalent
Regulation	872.1800

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Source

View the full FDA submission: accessdata.fda.gov

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HyperLight Portable X-ray Unit

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