Name: Predicase
Price: 199 USD

K-number	K213516
Device name	Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 with Distributed Multi Nudclei
Applicant	Philips Medical Systems Nederland B.V.
Product code	LNH
Device class	Class II
Decision date	Mar 3, 2022
Decision	Substantially Equivalent
Regulation	892.1000

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Source

View the full FDA submission: accessdata.fda.gov

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Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 with Distributed Multi Nudclei

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