FDA 510(k), K203782, Nanox Cart X-ray System

510(K) Number: K203782
Device Name: Nanox Cart X-ray System
Manufacturer: Yuval Shapiro
Device Classification Name: System, X-Ray, Mobile
Regulation Number: IZL
Classification Product Code: 12/28/2020
Date Received: 04/01/2021
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology

NOTE: 806 of the original 1,542 pages were fully redacted and removed from the file.