Name: Predicase
Price: 199 USD

K-number	K152859
Device name	Portable X-ray System (Model: MINIX-V / MINIX-S)
Applicant	Digimed Co., Ltd. (Digimed Corporation Until 31/12/2012)
Product code	EHD
Device class	Class II
Decision date	Dec 3, 2015
Decision	Substantially Equivalent
Regulation	872.1800

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Source

View the full FDA submission: accessdata.fda.gov

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Portable X-ray System (Model: MINIX-V / MINIX-S)

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