Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009090417

FEI Number

3009090417

Entity Name

GMV Soluciones Global Internet SAU

City/State/Country

Tres Cantos Madrid (Province), ES

Establishment Address

Isaac Newton 11, Tres Cantos Madrid (Province) 28760, ES

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

GMV Soluciones Global Internet SAU (Owner Number: 10041328)

Owner / Operator Contact Address

Isaac Newton 11, Madrid, ES-M 28760, ES

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K153368

PMA Number

N/A

All Registered Proprietary Names

Radiance v3

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MUJ	System, Planning, Radiation Therapy Treatment	Radiology	Class 2	892.5050	2017-01-19

Official Correspondent

Mindy McCann

US Agent Details

Mindy McCann Business: Qserve Group US Inc. Email: usagent@qservegroup.com Phone: (424) 2718169

Related Public Records

Same Entity

GMV Soluciones Global Internet SAU

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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009090417. Last updated year: 2026. Please use registration number 3009090417 when referencing this establishment in official correspondence.