Name: Predicase
Price: 199 USD

K-number	K130318
Device name	NEXUS DRF DIGITAL X-RAY IMAGING SYSTEM (WITH PAXSCAN 4343CB)
Applicant	Varian Medical Systems, X-Ray Products-Infimed
Product code	JAA
Device class	Class II
Decision date	Apr 22, 2013
Decision	Substantially Equivalent
Regulation	892.1650

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Source

View the full FDA submission: accessdata.fda.gov

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NEXUS DRF DIGITAL X-RAY IMAGING SYSTEM (WITH PAXSCAN 4343CB)

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