K-number	K200622
Device name	Focus 43C detector, TRIMAX 43C detector
Applicant	Iray Technology Taicang , Ltd.
Product code	MQB
Device class	Class II
Decision date	Apr 1, 2020
Decision	Substantially Equivalent
Regulation	892.1680

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Source

View the full FDA submission: accessdata.fda.gov

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Focus 43C detector, TRIMAX 43C detector

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