Name: Predicase
Price: 199 USD

K-number	K232021
Device name	Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T
Applicant	Philips Healthcare (Suzhou) Co., Ltd.
Product code	MOS
Device class	Class II
Decision date	Sep 1, 2023
Decision	Substantially Equivalent
Regulation	892.1000

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Source

View the full FDA submission: accessdata.fda.gov

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Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T

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