Name: Predicase
Price: 199 USD

K-number	K093857
Device name	C7 XR IMAGING SYSTEM WITH C7 DRAGONFLY IMAGING CATHETER AND DISPOSABLE ACCESSORIES
Applicant	Lightlab Imaging, Inc.
Product code	NQQ
Device class	Class II
Decision date	Apr 30, 2010
Decision	Substantially Equivalent
Regulation	892.1560

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Source

View the full FDA submission: accessdata.fda.gov

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C7 XR IMAGING SYSTEM WITH C7 DRAGONFLY IMAGING CATHETER AND DISPOSABLE ACCESSORIES

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