K-number	K211980
Device name	SIGNA Prime
Applicant	Ge Healthcare (Tianjin) Company Limited
Product code	LNH
Device class	Class II
Decision date	Jan 16, 2022
Decision	Substantially Equivalent
Regulation	892.1000

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Source

View the full FDA submission: accessdata.fda.gov

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SIGNA Prime

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