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510(k) K252649

TAP2D by Nano-X Imaging , Ltd. — Product Code IZF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 2, 2026
Date Received
August 21, 2025
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

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  • K132261 — DISCOVERY XR656 WITH VOLUMERAD (DIGITAL TOMOSYNTHESIS) (November 18, 2013)
  • K121499 — FUJIFILM TOMOSYNTHESIS OPTION FOR FDR ACSELERATE STATIONARY X-RAY SYSTEM (November 20, 2012)