K-number	K231761
Device name	PodSKAN HF Diagnostic X-ray System
Applicant	Skanray Technologies Limited
Product code	KPR
Device class	Class II
Decision date	Oct 27, 2023
Decision	Substantially Equivalent
Regulation	892.1680

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Source

View the full FDA submission: accessdata.fda.gov

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PodSKAN HF Diagnostic X-ray System

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