Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3022378058

FEI Number

3022378058

Entity Name

RADIACTION LTD.

City/State/Country

Tel Aviv, IL

Establishment Address

10 HaNechoshet St., Tel Aviv 6971072, IL

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Radiaction Ltd. (Owner Number: 10084821)

Owner / Operator Contact Address

10 HaNechoshet St., Tel Aviv, IL-TA 6971072, IL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K212159

PMA Number

N/A

All Registered Proprietary Names

Shield System Shield System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2022-12-01
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2022-04-11

Official Correspondent

No official correspondent registered.

US Agent Details

Will McGuire Email: will@radiactionmedical.com Phone: (858) 2453090

Related Public Records

Same Entity

Radiaction Ltd.

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K163715	Philips Medical Systems Nederland B.V.	Allura Xper R9	2017-01-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2026	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands	2	Allura Xper FD10C; Model Number: 722001; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Z-0002-2026	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands	2	Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Z-0003-2026	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands	2	Allura Xper FD10/10; Model Numbers: (1) 722005, (2) 722011, (3) 722027; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Z-0004-2026	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands	2	Allura Xper FD10 OR Table; Model Numbers: 722033; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Z-0005-2026	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands	2	Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

Similar Registrations

Registration Number	Establishment Name	Location
3021027284	ANGIOWAVE IMAGING, INC.	Concord, MA, US
3042175844	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.	BEST Noord-Brabant, NL
3027373189	LIBERTY GLOBAL, LLC	Scottsdale, AZ, US
3033527282	Philips India Limited - Image Guided Therapy Systems Business Unit	Bengaluru Karnataka, IN
9614698	CANON INC.	OTAWARA-SHI Tochigi, JP

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3022378058. Last updated year: 2026. Please use registration number 3022378058 when referencing this establishment in official correspondence.