Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3022810909

FEI Number

3022810909

Entity Name

Dagesh F.K. Ltd.

City/State/Country

Yad Binyamin Central, IL

Establishment Address

6 Ovaia street, Yad Binyamin Central 7681200, IL

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

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

N/A

PMA Number

N/A

All Registered Proprietary Names

Nanox.ARC Nanox.ARC X

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
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 Business: Nanox Imaging Inc. 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
3027605321	NANO-X IMAGING LTD	PETAH TIKVA 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
3011825597	FAIR MEDICAL CO.,LTD	Kashiwa Chiba, JP
3008284470	GE Healthcare (China) Co., Ltd.	Beijing, CN
2126677	GE MEDICAL SYSTEMS, LLC	Waukesha, WI, US
3027605321	NANO-X IMAGING LTD	PETAH TIKVA Central, IL
9616047	GE MEDICAL SYSTEMS MONTERREY MEXICO, S.A. DE C.V.	APODACA Nuevo Leon, MX

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3022810909. Last updated year: 2026. Please use registration number 3022810909 when referencing this establishment in official correspondence.