Name: Predicase
Price: 199 USD

K-number	K163624
Device name	Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600)
Applicant	Fujifilm Medical Systems U.S.A, Inc.
Product code	MQB
Device class	Class II
Decision date	Jun 30, 2017
Decision	Substantially Equivalent
Regulation	892.1680

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Source

View the full FDA submission: accessdata.fda.gov

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Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600)

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