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510(k) K242395

Nanox.ARC by Nano-X Imaging , Ltd. — Product Code IZF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 4, 2024
Date Received
August 13, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Tomographic
Device Class
Class II
Regulation Number
892.1740
Review Panel
RA
Submission Type

Other clearances by Nano-X Imaging , Ltd.

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  • K203782 — Nanox Cart X-ray System (April 1, 2021)

Other clearances for product code IZF

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  • K252133 — Adaptix Ortho350 (November 6, 2025)
  • K250850 — Nanox.ARC X (April 16, 2025)
  • K222934 — Nanox.ARC (April 28, 2023)
  • K221949 — Ortho Device, ADAPTIX 3D Orthopedic Imaging System (January 26, 2023)
  • K213081 — CLISIS SYSTEMS, Discovery RF180 (October 26, 2021)
  • K193262 — DR 600 with Tomosynthesis (March 9, 2020)
  • K183275 — DR 800 with Tomosynthesis (February 1, 2019)
  • K132261 — DISCOVERY XR656 WITH VOLUMERAD (DIGITAL TOMOSYNTHESIS) (November 18, 2013)
  • K121499 — FUJIFILM TOMOSYNTHESIS OPTION FOR FDR ACSELERATE STATIONARY X-RAY SYSTEM (November 20, 2012)