K-number	K192512
Device name	Focus 35C Detector, Trimax 35C Detector
Applicant	Iray Technology Taicang , Ltd.
Product code	MQB
Device class	Class II
Decision date	Oct 16, 2019
Decision	Substantially Equivalent
Regulation	892.1680

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View the full FDA submission: accessdata.fda.gov

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Focus 35C Detector, Trimax 35C Detector

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