K-number	K213941
Device name	Annalise Enterprise CXR Triage Pneumothorax
Applicant	Annalise-Ai
Product code	QFM
Device class	Class II
Decision date	Feb 24, 2022
Decision	Substantially Equivalent
Regulation	892.2080

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Source

View the full FDA submission: accessdata.fda.gov

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Annalise Enterprise CXR Triage Pneumothorax

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