K-number	K131233
Device name	HERMES MEDICAL IMAGING SUITE V5.3
Applicant	Hermes Medical Solutions AB
Product code	KPS
Device class	Class II
Decision date	Jul 16, 2013
Decision	Substantially Equivalent
Regulation	892.1200

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Source

View the full FDA submission: accessdata.fda.gov

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HERMES MEDICAL IMAGING SUITE V5.3

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