Name: Predicase
Price: 199 USD

K-number	K133664
Device name	ENCORE VERSION 16 SOFTWARE FOR GE LUNAR DXA BONE DENSITOMETERS
Applicant	Ge Medical Systems Ultrasound & Primary Care Diagn
Product code	KGI
Device class	Class II
Decision date	May 15, 2014
Decision	Substantially Equivalent
Regulation	892.1170

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Source

View the full FDA submission: accessdata.fda.gov

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ENCORE VERSION 16 SOFTWARE FOR GE LUNAR DXA BONE DENSITOMETERS

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