Name: Predicase
Price: 199 USD

K-number	K223491
Device name	Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite
Applicant	Ge Medical Systems, LLC
Product code	QBS
Device class	Class II
Decision date	May 25, 2023
Decision	Substantially Equivalent
Regulation	892.2090

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Source

View the full FDA submission: accessdata.fda.gov

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Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite

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