Manufacturer

Elekta

Finland, SwedenLegal entities : Elekta Oy, Elekta Solutions AB

Markets : Belgium · Croatia · Czechia · Finland · France · Germany · Italy · Netherlands · Romania · Slovakia · Spain · Sweden · United States

Approvals : EU – class I, IIa, IIb · United States (FDA) – 510(k) : 39 · class I, II · latest in 2026 · see on the FDA website

Public contracts won : France 28 · Czechia 10 · Netherlands 5 · Slovakia 5 · Germany 3 · Romania 3 · Spain 3 · Belgium 2 · Italy 2 · Croatia 1

Website

9 categories, 18 models including 17 on the market, 2 countries

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On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a category to see competitors, a model to open its EUDAMED record.

Category	EMDN code	Registered models	Class	Contact
Stereotactic neurosurgery systems	Z12100601	CT-Adapter, Adjustable Leksell Stereotactic System (Class I)3 refs DISPOSABLE INSERTS 4 PCS FirmFix 13 refs FirmFix Ruler Leksell Vantage Stereotactic System (Class I)3 refs FIXATION SCREW 110MM TITANIUM Fixation Screws 20mm-110mm3 refs 2 others Frame G with Straight/Curved Front Leksell Stereotactic System (Class I(m))3 refs Leksell Vantage Arc System (Class Im)	I, IIa MDR	EUDAMED record Report an error
Various radiotherapy and radiosurgery instruments - other	Z11019099	Elekta Esprit Leksell Gamma Knife 113 refs Icon Patient Cushion KLARITY3 refs Skull Scaling Instrument	I, IIb MDR	EUDAMED record Report an error
Various neurology and neurosurgery instruments - other	Z12109099	GUIDE WITH 1,5 MM HOLE Stop & Guide3 refs STERILIZING TRAY / SMALL Sterilization Tray	I MDR	EUDAMED record Report an error
Brachytherapy radiation systems	Z11010301	Axxent Electronic Brachytherapy System	IIb MDR	EUDAMED record Report an error
Brachytherapy radiation systems - hardware accessories	Z11010380	Axxent Balloon Applicator - 3-4cm spherical3 refs	IIa MDR	EUDAMED record Report an error
Linear accelerators - hardware accessories	Z11010180	Visual Guidance	I MDR	EUDAMED record Report an error
Radiosurgery instruments - software accessories	Z11010782	Leksell GammaPlan 11.42 refs	IIb MDR	EUDAMED record Report an error
Radiotherapy treatment planning instruments - medical device software	Z11010492	Oncentra Brachy	IIb MDR	EUDAMED record Report an error
General medicine diagnosis and monitoring instruments - medical device software No model still on the market	Z12040192	Kaiku Health Major version 793/42 (no longer marketed)	IIa 93/42	EUDAMED record Report an error

A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.

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