Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3036107971

FEI Number

3036107971

Entity Name

VOXEL RAY SOLUTIONS, LLC

City/State/Country

Burr Ridge, IL, US

Establishment Address

200 S Frontage Rd Ste 200, Burr Ridge, IL 60527, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Voxel Ray Solutions, LLC (Owner Number: 10092818)

Owner / Operator Contact Address

200 S Frontage Rd, STE 200, Burr Ridge, IL 60527, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K250692

PMA Number

N/A

All Registered Proprietary Names

GentleBeam

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	2025-12-10

Official Correspondent

Nicolas Soro

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Voxel Ray Solutions, LLC

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

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

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
9611894	NUCLETRON B.V.	VEENENDAAL Utrecht, NL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3036107971. Last updated year: 2026. Please use registration number 3036107971 when referencing this establishment in official correspondence.