TAP2D

FDA 510(k) K252649 · Nano-X Imaging , Ltd.

Substantially Equivalent

510(k) numberK252649

Submission

Device name
TAP2D
Applicant
Nano-X Imaging , Ltd.
Petah Tikva, IL
Received
August 21, 2025
Decision date
February 2, 2026
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
IZF – System, X-Ray, Tomographic
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1740
Specialty
Radiology

Other 510(k)s with product code IZF

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K252133Adaptix Ortho350IZF · Traditional Adaptix Limited11/06/2025SE
K250850Nanox.ARC XIZF · Traditional Nano-X Imaging , Ltd.04/16/2025SE
K242395Nanox.ARCIZF · Traditional Nano-X Imaging , Ltd.12/04/2024SE
K222934Nanox.ARCIZF · Traditional Nano-X Imaging , Ltd.04/28/2023SE
K221949Ortho Device, ADAPTIX 3D Orthopedic Imaging SystemIZF · Traditional Pausch Medical GmbH01/26/2023SE
K213081CLISIS SYSTEMS, Discovery RF180IZF · Traditional General Medical Merate S.P.A10/26/2021SE
K193262DR 600 with TomosynthesisIZF · Traditional Agfa N.V.03/09/2020SE
K183275DR 800 with TomosynthesisIZF · Traditional Agfa N.V.02/01/2019SE
K132261Discovery XR656 with Volumerad (Digital Tomosynthesis)IZF · Traditional Ge Medical Systems, LLC11/18/2013SE
K121499Fujifilm Tomosynthesis Option for FDR Acselerate Stationary X-Ray SystemIZF · Traditional Fujifilm Medical System U.S.A., Inc.11/20/2012SE

More from Fujifilm Medical System U.S.A., Inc.

510(k)DeviceDecision
K250850Nanox.ARC XIZF · Traditional 04/16/2025SE
K242395Nanox.ARCIZF · Traditional 12/04/2024SE
K222934Nanox.ARCIZF · Traditional 04/28/2023SE
K203782Nanox Cart X-ray SystemIZL · Traditional 04/01/2021SE

Questions and answers

When was TAP2D cleared by the FDA?

TAP2D (K252649) received a 510(k) decision of Substantially Equivalent on February 2, 2026, 165 days after the submission was received.

What is the product code of K252649?

The FDA product code is IZF – System, X-Ray, Tomographic, a Class II (moderate risk) device regulated under 21 CFR 892.1740.