K-number	K172581
Device name	CareView 1800Cw X-ray Flat Panel Detectors
Applicant	Careray Digital Medical System Co., Ltd.
Product code	MQB
Device class	Class II
Decision date	Sep 26, 2017
Decision	Substantially Equivalent
Regulation	892.1680

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Source

View the full FDA submission: accessdata.fda.gov

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CareView 1800Cw X-ray Flat Panel Detectors

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