K-number	K180393
Device name	AIRO Computed Tomography (CT) X-ray System
Applicant	Mobius Imaging, LLC
Product code	JAK
Device class	Class II
Decision date	Mar 15, 2018
Decision	Substantially Equivalent
Regulation	892.1750

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Source

View the full FDA submission: accessdata.fda.gov

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AIRO Computed Tomography (CT) X-ray System

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