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510(k) K252133

Adaptix Ortho350 by Adaptix Limited — Product Code IZF

K252133 is an FDA 510(k) premarket notification submitted by Adaptix Limited for the device "Adaptix Ortho350". The FDA issued a decision of Substantially Equivalent on November 6, 2025. The device falls under product code IZF (System, X-Ray, Tomographic), a Class II device regulated under 21 CFR 892.1740.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 6, 2025
Date Received
July 7, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

Other clearances for product code IZF

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  • K250850 — Nanox.ARC X (April 16, 2025)
  • K242395 — Nanox.ARC (December 4, 2024)
  • 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)

FDA data resources