K-number	K231001
Device name	DeepTek CXR Analyzer v1.0
Applicant	Deeptek Medical Imaging Pvt, Ltd.
Product code	MYN
Device class	Class II
Decision date	Oct 5, 2023
Decision	Substantially Equivalent
Regulation	892.2070

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Source

View the full FDA submission: accessdata.fda.gov

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DeepTek CXR Analyzer v1.0

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