Name: Predicase
Price: 199 USD

K-number	K082364
Device name	IMAGENET PROFESSIONAL PC SOFTWARE SYSTEM OR IMAGENET PROFESSIONAL, OR IMAGENET PRO, OR DIGITAL IMAGING SOFTWARE FOR
Applicant	Topcon Corp.
Product code	NFJ
Device class	Class II
Decision date	Sep 30, 2008
Decision	Substantially Equivalent
Regulation	892.2050

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Source

View the full FDA submission: accessdata.fda.gov

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IMAGENET PROFESSIONAL PC SOFTWARE SYSTEM OR IMAGENET PROFESSIONAL, OR IMAGENET PRO, OR DIGITAL IMAGING SOFTWARE FOR

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