TAP2D

Basic Information

• Brand Name: TAP2D
• Primary DI: 07290018465066
• Version / Model: 1.0
• Company Name: NANO-X IMAGING LTD
• Labeler DUNS: 521092973
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-02-18
• Public Version: 1
• Public Version Date: 2026-02-26
• Public Version Status: New
• Public Device Record Key: 38361133-daae-472c-a982-765ba3a3641c

Device Description

TAP2D is a cloud-based software-module accessory intended exclusively for use with the Nanox.ARC X and Nanox.ARC systems, consistent with their cleared indications for use. TAP2D is intended to provide a supplemental processed and enhanced 2D view image in DICOM format of a single 2D projection extracted from the acquired DTS study. TAP2D is specifically indicated for assisting radiologists when evaluating diagnostic tomosynthesis studies and reaching their own diagnosis.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IZF	System, X-Ray, Tomographic	Radiology	892.1740	2
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	892.1680	2
LLZ	System, Image Processing, Radiological	Radiology	892.2050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37660	Multi-directional tomography x-ray system	An assembly of devices used to produce 2-dimensional cross-sectional (tomographic) images on x-ray film at a fixed angle and depth in relation to body position by coordinating a prescribed pattern of non-linear x-ray tube motion (elliptical, circular, clover shaped, spiral, as well as linear, depending on the system design) during exposure sequences. This approach causes the shadow of the selected plane to remain stationary on the moving film while the shadows in both directions of the plane have a relative displacement on the film and are either obliterated or blurred. This GMDN code reflects old technology, now superseded by computed tomography (CT) systems.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290018465066	GS1

Premarket Submissions

Submission Number	Supplement Number
K252649	000