Name: Predicase
Price: 199 USD

K-number	K232178
Device name	GXR-ES/ECS Diagnostic X-Ray System, (Models GXR-ES series, GXR-ECS series)
Applicant	DRGEM Corporation
Product code	KPR
Device class	Class II
Decision date	Sep 19, 2023
Decision	Substantially Equivalent
Regulation	892.1680

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Source

View the full FDA submission: accessdata.fda.gov

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GXR-ES/ECS Diagnostic X-Ray System, (Models GXR-ES series, GXR-ECS series)

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