Name: Predicase
Price: 199 USD

K-number	K110801
Device name	WV3000T DIGITAL X-RAY DIRECT IMAGING FLAT PANEL DETECTOR SYSTEM
Applicant	Direct Digital Imaging Technology (Beijing), Inc.
Product code	MQB
Device class	Class II
Decision date	Aug 2, 2011
Decision	Substantially Equivalent
Regulation	892.1680

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Source

View the full FDA submission: accessdata.fda.gov

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WV3000T DIGITAL X-RAY DIRECT IMAGING FLAT PANEL DETECTOR SYSTEM

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