K-number	K081091
Device name	PRECISION 500D R&F X-RAY SYSTEM
Applicant	GE Healthcare
Product code	JAA
Device class	Class II
Decision date	Jun 11, 2008
Decision	Substantially Equivalent
Regulation	892.1650

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Source

View the full FDA submission: accessdata.fda.gov

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PRECISION 500D R&F X-RAY SYSTEM

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