Name: Predicase
Price: 199 USD

K-number	K171303
Device name	Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664
Applicant	University of Texas Medical School AT Houston, Texas
Product code	KPS
Device class	Class II
Decision date	Sep 22, 2017
Decision	Substantially Equivalent
Regulation	892.1200

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Source

View the full FDA submission: accessdata.fda.gov

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Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664

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