Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014425747

FEI Number

3014425747

Entity Name

COSYLAB, JCS, CONTROL SYSTEM LABORATORY

City/State/Country

Ljubljana, SI

Establishment Address

Gerbiceva Ulica 64, Ljubljana 1000, SI

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Cosylab, JCS, Control System Laboratory (Owner Number: 10094594)

Owner / Operator Contact Address

Gerbiceva Ulica 64, Ljubljana, SI-NOTA 1000, SI

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K250963

PMA Number

N/A

All Registered Proprietary Names

PlanOne

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	2025-12-09

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar corp Email: David.Lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Cosylab, JCS, Control System Laboratory

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 3014425747. Last updated year: 2026. Please use registration number 3014425747 when referencing this establishment in official correspondence.