Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004561814

FEI Number

3004561814

Entity Name

XSTRAHL LIMITED

City/State/Country

WALSALL, WEST MIDLANDS Staffordshire, GB

Establishment Address

UNIT 2, MAYBROOK ROAD, WALSALL, WEST MIDLANDS Staffordshire WS8 7DG, GB

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

XSTRAHL LIMITED (Owner Number: 9026784)

Owner / Operator Contact Address

UNIT 2, MAYBROOK ROAD, WALSALL, WEST MIDLANDS, GB-NOTA WS8 7DG, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K230611

PMA Number

N/A

All Registered Proprietary Names

Xstrahl 300 Xstrahl 200 Xstrahl 100 X80 RADiant Photoelectric Therapy System XBeam (v2) RADiant Aura

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JAD	System, Therapeutic, X-Ray	Radiology	Class 2	892.5900	2004-05-07
JAD	System, Therapeutic, X-Ray	Radiology	Class 2	892.5900	2017-11-10
MUJ	System, Planning, Radiation Therapy Treatment	Radiology	Class 2	892.5050	2026-01-08
JAD	System, Therapeutic, X-Ray	Radiology	Class 2	892.5900	2023-12-19

Official Correspondent

Sajid Rafiq

US Agent Details

Adrian Treverton Business: XSTRAHL, INC. Email: atreverton@xstrahl.com Phone: (678) 7658970

Related Public Records

Same Entity

XSTRAHL LIMITED

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
K241174	Carl Zeiss Meditec, AG	INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Set, INTRABEAM Needle Applicator)	2025-01-10
K993675	Nomos Corp.	PEREGRINE RADIATION THERAPY DOSE CALCULATION SYSTEM	2000-09-05

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2018	Carl Zeiss Meditec AG Rudolf-Eber-Str. 11 Oberkochen Germany	2	Carl Zeiss INTRABEAM PRS 500, product #304534-0000-500. The firm name on the label is Carl Zeiss Meditec AG, Jena, Germany. The INTRABEAM System is indicated for radiation therapy treatments
Z-0014-2012	Elekta, Inc.	2	Dynamic Multileaf Collimator (DMLC) Shapes the radiation beam in treatment therapy.
Z-0038-2017	RAYSEARCH LABORATORIES AB Sveavaegen 9 Stockholm Sweden	2	RayStation 2.5, 3.0, 3.5, 4.0, 4.5, 4.7, 5.0 and 4.3 (InverseArc 1.0) -- Radiation Therapy Treatment Planning System RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs.

Similar Registrations

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3032638959	Elekta Inc.	San Jose, CA, US
3015232217	ELEKTA SOLUTIONS AB	STOCKHOLM, SE
3030230020	KOPLAK CORP	Sunrise, FL, US
9615010	CARL ZEISS MEDITEC AG (OBERKOCHEN)	OBERKOCHEN Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004561814. Last updated year: 2026. Please use registration number 3004561814 when referencing this establishment in official correspondence.