Bioimaging and radiotherapy instrumentsRadiotherapy and radiosurgery instrumentsVarious radiotherapy and radiosurgery instruments

Various radiotherapy and radiosurgery instruments - other

EMDN code Z11019099

17 manufacturers, 44 models including 42 on the market, 11 countries

On the market in Models on the market only Manufacturer country

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Manufacturers registered in Europe (EUDAMED) 17

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

Manufacturer	Country	Registered models	Class	Contact
Xstrahl FDA EU representative : Advena Limited (Malta)	United Kingdom (ex Northern Ireland)	Xstrahl 100 Therapeutic X-Ray System93/42 Xstrahl 150 Therapeutic X-Ray System - Ceiling93/42 Xstrahl 150 Therapeutic X-Ray System - Floor93/42 Xstrahl 200 Therapeutic X-Ray System - Floor93/42 Xstrahl 200 Therapeutic X-Ray System Xstrahl 200 X-Ray System - Ceiling93/42 3 others Xstrahl 300 Therapeutic X-Ray System - Ceiling93/42 Xstrahl 300 Therapeutic X-Ray System - Floor93/42 Xstrahl 80 Therapeutic X-Ray System (RADiant)93/42	IIb 93/42	Website support@xstrahl.com EUDAMED record Report an error
Dyn'R FDA	France	Gating Module 4D -CT - Siemens Somatom93/42 Gating Module PT93/42 Gating Module RT - IBA Proteus93/42 Gating Module RT - Varian Probeam93/42 SDX System 3.093/42 2 others SDX System and Medikro syringe Gating Module RT - Varian TrueBeam93/42 (no longer marketed)	IIb MDR, 93/42	Website EUDAMED record Report an error
Standard Imaging FDA EU representative : Hoff & Lowendahl AB (Sweden)	United States	Exradin D1H Diode2 refs Exradin W1 Scintillator QA BeamChecker Plus3 refs TruPose Head Adjuster	I MDR	Website EUDAMED record Report an error
Vision RT FDA EU representative : Oticon A/S (Denmark)	United Kingdom (ex Northern Ireland)	AlignRT 5.13 refs DoseRT camera3 refs Horizon CR2 refs RTC3 refs	I, IIb MDR	Website info@visionrt.com EUDAMED record Report an error
Elekta FDA	Sweden	Elekta Esprit Leksell Gamma Knife 113 refs Icon Patient Cushion KLARITY3 refs Skull Scaling Instrument	I, IIb MDR	EUDAMED record Report an error
Fondazione Centro Nazionale Di Adroterapia Oncologica	Italy	CNAO-01 DDS/FIX3 refs DDS/GAN	IIb MDR	EUDAMED record Report an error
Gilardoni FDA	Italy	RADGIL2 X-BEAM	IIb MDR	Website EUDAMED record Report an error
Medaustron	Austria	MAPTA MATEO	IIb MDR	Website EUDAMED record Report an error
Raydose EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	BC-759 MC-Plus	I MDR	EUDAMED record Report an error
Sensus Healthcare FDA EU representative : Emergo Europe B.V. (Netherlands)	United States	SRT-100™93/42 SRT-100 Vision™93/42 (no longer marketed)	IIb 93/42	EUDAMED record Report an error
Blessing Cathay FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	Taiwan	Conformal Bolus – AquaCast3 refs	I MDR	info@bcc.taipei EUDAMED record Report an error
Brainlab FDA	Germany	ExacTrac Dynamic, 1.13 refs	IIb MDR	regulatory.affairs@brainlab.com EUDAMED record Report an error
Hemodia FDA	France	SET PREPARATION RADIO MARQUAGE	IIa MDR	EUDAMED record Report an error
Medtronic FDA EU representative : Medtronic B.V. (Netherlands)	United States	O-Arm O2 Imaging System	IIb MDR	EUDAMED record Report an error
Orfit FDA	Belgium	Thermofit 13.5 x 30 cm Head Support3 refs	I MDR	Website EUDAMED record Report an error
ScandiDos FDA	Sweden	Delta4 Phantom+	I MDR	Website info@scandidos.com EUDAMED record Report an error
Siho	Spain	ALZA 2 CMS3 refs	I MDR	Website info@siho.es 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.

Other manufacturers known in the United States (FDA) 10

Manufacturers selling this type of device in the United States according to the FDA, not yet in EUDAMED for this category. Some do sell in Europe: registration of devices already on the market is mandatory until 28 November 2026, and some are registered under their parent company’s name. The category is inferred automatically from the US classification and may include related products.

Manufacturer	Country	Brands	FDA clearance
Xcision Medical Systems, LLC	United States	GammaPod™ Breast Immobilization and Localization System GammaPod™ GammaPod™ Imager Loader and Couch GammaPod™ Treatment Control System GammaPod™ Treatment Planning System	K180571 (2018)
Elekta Instrument AB	Sweden	Leksell Gamma Knife Perfexion/Icon Leksell Gamma Knife Icon Leksell GammaPlan Leksell Gamma Knife C 4 4C Leksell Gamma Knife Perfexion Leksell Stereotactic System	K173789 (2018)
Sun Nuclear Corp. Present in Europe in other categories	United States	ISORAD Detector, 1-4MV (+) 3m ISORAD Detector, 6-12MV (-) 1.5m ISORAD Detector, 6-12MV (-) 3m ISORAD Detector, 6-12MV (+) 3m ISORAD Detector, 1-4MV (-) 3m ISORAD Detector, 15-25MV (-) 1.5m	registered
Best Theratronics Ltd	Canada	GammaBeam Theratron	K150191 (2015)
Our Smd Medical (Wuhan) Co., Ltd.	China	SMD-XGD/AR Galaxy SMD Galaxy RTx	registered
Akesis, Inc.	United States	Galaxy RTi	K203146 (2021)
Our United Corporation	China	CybeRay	K203250 (2021)
BEST MEDICAL INTERNA	United States	–	registered
Masep Medical Science & Tech.Development (Shenzhen	United States	–	K102533 (2011)
Prowess, Inc.	United States	–	registered

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