Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3027605321

FEI Number

3027605321

Entity Name

NANO-X IMAGING LTD

City/State/Country

PETAH TIKVA Central, IL

Establishment Address

94 Em Hamoshavot Road, Brosh building Ofer Tech Park PO Box 3486, PETAH TIKVA Central 4910402, IL

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Nano-X Imaging Ltd (Owner Number: 10088182)

Owner / Operator Contact Address

94 Em Hamoshavot Road, Brosh building Ofer Tech Park PO Box 3486, PETAH TIKVA, IL-M 4910402, IL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K250850

PMA Number

N/A

All Registered Proprietary Names

Nanox.ARC Nanox.ARC Nanox.ARC X

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2023-06-07
IZF	System, X-Ray, Tomographic	Radiology	Class 2	892.1740	2023-06-07
IZF	System, X-Ray, Tomographic	Radiology	Class 2	892.1740	2024-12-23
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2024-12-23
IZF	System, X-Ray, Tomographic	Radiology	Class 2	892.1740	2025-05-11
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2025-05-11

Official Correspondent

Noa First

US Agent Details

Ran Daniel Email: ran.d@nanox.vision Phone: (212) 9820269

Related Public Records

Same Entity

Nano-X Imaging Ltd

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3022810909	Dagesh F.K. Ltd.	Yad Binyamin Central, IL

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K070563	Vidar Systems Corp.	VIDAR VISION 2000	2007-03-16
K190691	Pixxgen Corporation	Pixx2430 Digital Diagnostic X-Ray Receptor Panel	2019-04-04
K150150	Rayence Co., Ltd.	1717SGN / 1717SCN Digital Flat Panel X-ray Detector	2015-03-27
K140771	Philips Medical Systems Dmc GmbH	PHILIPS ELEVA WORKSPOT	2014-04-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0005-2009	Toshiba American Medical Systems Inc	2	Toshiba Infinix fluoroscopy DFP-8000D Digital Radiography System with version 3.40 or higher software. Controller for Infinix interventional angiography systems.
Z-0031-2007	AGFA Corp.	2	CR DX-S, Image Intensified Fluoroscopic X-ray system.

Similar Registrations

Registration Number	Establishment Name	Location
3016256852	KA IMAGING INC.	Waterloo Ontario, CA
3011825597	FAIR MEDICAL CO.,LTD	Kashiwa Chiba, JP
3038614464	Canon.Inc	OHTA-KU Tokyo, JP
9614698	CANON INC.	OTAWARA-SHI Tochigi, JP
3003775006	FUJIFILM Healthcare Manufacturing Corporation Hanamaki Office	HANAMAKI-SHI Iwate, JP

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027605321. Last updated year: 2026. Please use registration number 3027605321 when referencing this establishment in official correspondence.