K-number	K180989
Device name	PEDRA-17F Digital Flat Panel X-ray Detector
Applicant	Radisen, Inc.
Product code	MQB
Device class	Class II
Decision date	Jun 13, 2018
Decision	Substantially Equivalent
Regulation	892.1680

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View the full FDA submission: accessdata.fda.gov

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PEDRA-17F Digital Flat Panel X-ray Detector

Everything you need for a 510(k) submission. Nothing you don't.