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Emdyca

Bioimaging and radiotherapy instrumentsRadiotherapy and radiosurgery instruments

Radiosurgery instruments

EMDN code Z110107

1 manufacturer, 1 model including 1 on the market, 1 country

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Manufacturers registered in Europe (EUDAMED) 1
  • 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.
ManufacturerCountryRegistered modelsClassContact
Zapsurgical FDA EU representative : ICON (LR) Limited (Ireland) United States IIb MDR Website customerservice@zapsurgical.com 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.

ManufacturerCountryBrandsFDA 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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