K-number	K210811
Device name	Dynamyx Digital Pathology Software
Applicant	Inspirata, Inc.
Product code	QKQ
Device class	Class II
Decision date	Mar 1, 2022
Decision	Substantially Equivalent
Regulation	864.3700

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Source

View the full FDA submission: accessdata.fda.gov

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Dynamyx Digital Pathology Software

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