Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3044735888

FEI Number

3044735888

Entity Name

Anatomical Geometry S.L.

City/State/Country

MAIRENA DEL ALJARAFE Sevilla, ES

Establishment Address

C/ Formacion, 6, MAIRENA DEL ALJARAFE Sevilla 41927, ES

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Anatomical Geometry S.L. (Owner Number: 10095345)

Owner / Operator Contact Address

C/ Formacion Nave 6., MAIRENA DEL ALJARAFE, ES-SE 41927, ES

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K252784

PMA Number

N/A

All Registered Proprietary Names

eaSyFix eXaCast Thermoplastic Mask eXaSkin Plus

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KXH	Cradle, Patient, Radiologic	Radiology	Class 1	892.1830	2026-03-02
MUJ	System, Planning, Radiation Therapy Treatment	Radiology	Class 2	892.5050	2026-06-12
IXI	Block, Beam-Shaping, Radiation Therapy	Radiology	Class 2	892.5710	2026-06-12

Official Correspondent

Eduardo Suarez Martin

US Agent Details

David Holdford Business: Innovative Oncology Solutions, Inc Email: dholdford@innovativeoncology.com Phone: (800) 9930928

Related Public Records

Same Entity

Anatomical Geometry S.L.

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
K993675	Nomos Corp.	PEREGRINE RADIATION THERAPY DOSE CALCULATION SYSTEM	2000-09-05

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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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3012205931	GUANGZHOU TIAN HONG MEDICAL TECHNOLOGY CO., LTD.	Guangzhou Guangdong, CN
9613299	GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING	TIRAT HACARMEL Haifa, IL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3044735888. Last updated year: 2026. Please use registration number 3044735888 when referencing this establishment in official correspondence.