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Elekta Instrument AB

US

Last updated May 24, 2026

What Elekta Instrument AB makes

The company manufactures stereotactic systems for neurological surgery, including hardware for precision-guided procedures and associated software applications. These systems are designed for neurosurgical interventions, such as biopsies, tumor resections, and radiosurgery, using advanced targeting and imaging technologies. The portfolio also includes teletherapy radionuclide systems for conventional radiation therapy, though these are less frequently listed.

The devices fall under Class II regulatory classification in the US and are listed in the FDA’s Unique Device Identifier (UDI) database. The company’s headquarters are based in the United States, though its operations span global markets where applicable regulations apply.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Elekta Instrument AB manufacture?

Elekta Instrument AB specializes in stereotactic systems for neurological surgery, including hardware for precision-guided procedures like biopsies and tumor resections. Their portfolio also covers stereotactic system application software and teletherapy radionuclide systems for conventional radiation therapy. The most common devices are neurological stereotactic surgery systems, such as the Leksell Stereotactic System and its variants, which rely on advanced targeting and imaging technologies.

Where is Elekta Instrument AB based, and where are its devices primarily used?

Elekta Instrument AB is headquartered in the United States. While the company operates globally, its devices are designed to comply with applicable regulations in markets where they are used. The focus remains on precision neurosurgical and radiation therapy applications, particularly in regions with established medical infrastructure for these specialized procedures.

Which regulatory registries list Elekta Instrument AB’s devices?

Elekta Instrument AB’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for Class II devices, which include stereotactic systems and associated software. The UDI system helps healthcare providers and regulators identify and track these medical devices.

How are Elekta Instrument AB’s devices classified in the US?

Elekta Instrument AB’s devices fall under Class II regulatory classification in the US. This classification applies to devices that pose moderate risk and require special controls to ensure safety and effectiveness, such as precision-guided surgical systems and radiation therapy equipment. Class II devices undergo rigorous review to balance innovation with patient safety.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
US
Address
—
Website
elekta.com
LinkedIn
—
Facebook
—
Email
[email protected]
Phone
+1(855)693-5358
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
—
DUNS Number
507772663

Catalogue (393)

Page 8 of 8
DeviceModel / ReferenceRegistriesClassStatus
Leksell Stereotactic System 1002140
FDA UDI
Class IIActive
Leksell Stereotactic System A0401-14
FDA UDI
Class IIActive
Leksell Stereotactic System 13012720
FDA UDI
Class IIActive
Leksell Stereotactic System Neurosurgical Instruments 60081-25
FDA UDI
Class IIActive
Leksell Stereotactic System Neurosurgical Instruments 50378-01
FDA UDI
Class IIActive
Leksell Stereotactic System Neurosurgical Instruments 60080-60
FDA UDI
Class IIActive
Leksell Stereotactic System Neurosurgical Instruments A2600-01
FDA UDI
Class IIActive
Leksell Stereotactic System Neurosurgical Instruments 60377-02
FDA UDI
Class IIActive
Leksell Viewscope, Leksell Surgiscope, Leksell Freehand K973684
FDA 510(k)
Class IIActive
Leksell Gammaplan K090972
FDA 510(k)
Class IIActive
Leksell Gamma Knife Perfexion, Model 715000 K061941
FDA 510(k)
Class IIActive
Elekta Microdrive, Model 916716 K040979
FDA 510(k)
Class IIActive
Leksell Gamma Knife Icon K151561
FDA 510(k)
Class IIActive
Leksell Gammaplan K103093
FDA 510(k)
Class IIActive
Leksell Surgiplan With Imagemerge K033340
FDA 510(k)
Class IIActive
Modification To Leksell Surgiplan With Atlaspace K013861
FDA 510(k)
Class IIActive
Leksell Gammaplan K061540
FDA 510(k)
Class IIActive
Leksell Vantage Stereotactic System K171123
FDA 510(k)
Class IIActive
Leksell Gamma Knife Icon K160440
FDA 510(k)
Class IIActive
Elekta Leksell Stereotactic System With Mr Post Kit K031999
FDA 510(k)
Class IIActive
Leksell GammaPlan K151666
FDA 510(k)
Class IIActive
Leksell Image Guidance Surgical System, View Scope, Surgiscope, Elekta Insight K992882
FDA 510(k)
Class IIActive
Leksell Stereotactic System, Injection/ Aspiration Needle Kit K152558
FDA 510(k)
Class IIActive
Elekta Esarte Frame System K051746
FDA 510(k)
Class IIActive
Leksell Stereotactic System K972324
FDA 510(k)
Class IIActive
Modification To Leksell Stereotactic System K031980
FDA 510(k)
Class IIActive
Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon K173789
FDA 510(k)
Class IIActive
Leksell Gamma Knife Perfexion K151159
FDA 510(k)
Class IIActive
Stereotactic Body Frame K960338
FDA 510(k)
Class IIActive
Leksell Stereotactic System With Reusable Fixation Screws K080355
FDA 510(k)
Class IIActive
Leksell Surgiplan, Model 1006947 K080250
FDA 510(k)
Class IIActive
Leksell Gamma Knife Target System, Model 24001 K984328
FDA 510(k)
Class IIActive
Leksell Gamma Knife Perfexion K133565
FDA 510(k)
Class IIActive
Leksell Gammaplan 4c With Multiview K042269
FDA 510(k)
Class IIActive
Extend Frame System, Model 1009633 K092083
FDA 510(k)
Class IIActive
Accessories To The Stereotactic Body Fram K970291
FDA 510(k)
Class IIActive
Leksell Vantage Stereotactic System K190887
FDA 510(k)FDA UDI
Class IIActive
Gammaplan K051022
FDA 510(k)
Class IIActive
Elekta Stereotactic Guide K991636
FDA 510(k)
Class IIActive
Leksell GammaPlan K173791
FDA 510(k)
Class IIActive
Leksell Gamma Knife Perfexion K120811
FDA 510(k)
Class IIActive
Leksell Image Guidance Surgical System (ligs) K961639
FDA 510(k)
Class IIActive
Leksell Gamma Knife Perfexion K063512
FDA 510(k)
Class IIActive

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FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

  • Elekta Instrument AB Stockholm · SE FEI 3002806883