Name: Predicase
Price: 199 USD

K-number	K161459
Device name	Nexus DRTM Digital X-ray Imaging System (with PaxScan 4336Wv4)
Applicant	Varian Medical Systems, X-Ray Products-Infimed
Product code	MQB
Device class	Class II
Decision date	Sep 6, 2016
Decision	Substantially Equivalent
Regulation	892.1680

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Source

View the full FDA submission: accessdata.fda.gov

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Nexus DRTM Digital X-ray Imaging System (with PaxScan 4336Wv4)

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