Nanox Cart X-ray System

System, X-ray, Mobile

Nano-x Imaging Ltd.

The following data is part of a premarket notification filed by Nano-x Imaging Ltd. with the FDA for Nanox Cart X-ray System.

Pre-market Notification Details

Device IDK203782
510k NumberK203782
Device Name:Nanox Cart X-ray System
ClassificationSystem, X-ray, Mobile
Applicant Nano-x Imaging Ltd. Communications Center Building C, Entrance 1 Neve Ilan,  IL 9085000
ContactYuval Shapiro
CorrespondentRafael Aguila
Accelerated Device Approval Services 6800 S.W. 40th Street, Ste. 403 Ludlum,  FL  33155
Product CodeIZL  
CFR Regulation Number892.1720 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedYes
Combination ProductNo
Date Received2020-12-28
Decision Date2021-04-01

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