Name: Predicase
Price: 199 USD

K-number	K230140
Device name	TrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core 100Pro-US)
Applicant	Compai Healthcare (Suzhou) Co.,Ltd
Product code	MWP
Device class	Class II
Decision date	Apr 24, 2023
Decision	Substantially Equivalent
Regulation	892.1680

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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TrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core 100Pro-US)

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