Name: Predicase
Price: 199 USD

K-number	K231731
Device name	Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 4
Applicant	Mcgovern Medical School
Product code	KPS
Device class	Class II
Decision date	Aug 21, 2023
Decision	Substantially Equivalent
Regulation	892.1200

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Source

View the full FDA submission: accessdata.fda.gov

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Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 4

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