Name: Predicase
Price: 199 USD

K-number	K151219
Device name	Models 2200DR and 1600DR Digital Stationary Radiographic Systems
Applicant	Beijing Polycon Medical Engineering Company
Product code	KPR
Device class	Class II
Decision date	Aug 4, 2015
Decision	Substantially Equivalent
Regulation	892.1680

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Source

View the full FDA submission: accessdata.fda.gov

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Models 2200DR and 1600DR Digital Stationary Radiographic Systems

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