Name: Predicase
Price: 199 USD

K-number	K090062
Device name	WV1417A 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	May 18, 2009
Decision	Substantially Equivalent
Regulation	892.1680

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Source

View the full FDA submission: accessdata.fda.gov

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WV1417A DIGITAL X-RAY DIRECT IMAGING FLAT PANEL DETECTOR SYSTEM

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