Question 1

What types of medical devices does Elekta Instrument AB manufacture?

Accepted Answer

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.

Question 2

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

Accepted Answer

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.

Question 3

Which regulatory registries list Elekta Instrument AB’s devices?

Accepted Answer

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.

Question 4

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

Accepted Answer

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.

Device	Model / Reference	Registries	Class	Status
Leksell Stereotactic System	912877	FDA UDI	Class II	Active
Leksell Vantage Stereotactic System	1055515	FDA UDI	Class II	Active
Leksell Stereotactic System	1003679	FDA UDI	Class II	Active
Leksell Stereotactic System	1014734	FDA UDI	Class II	Active
Leksell Stereotactic System Neurosurgical Instruments	60081-21	FDA UDI	Class II	Active
Leksell Stereotactic System	13012630	FDA UDI	Class II	Active
Extend Frame system	1018275	FDA UDI	Class II	Unknown
Leksell Stereotactic System	302194	FDA UDI	Class II	Active
Leksell Stereotactic System Neurosurgical Instruments	911933	FDA UDI	Class II	Active
Leksell Stereotactic System	A0440-04	FDA UDI	Class II	Active
Leksell Stereotactic System	14010550	FDA UDI	Class II	Active
Leksell Stereotactic System	A0420-25	FDA UDI	Class II	Active
Leksell Vantage Stereotactic System	1072928	FDA UDI	Class II	Active
Leksell Stereotactic System Neurosurgical Instruments	60081-60	FDA UDI	Class II	Active
Leksell Stereotactic System	14010540	FDA UDI	Class II	Active
Leksell Stereotactic System	13012610	FDA UDI	Class II	Active
Leksell Stereotactic System	709673	FDA UDI	Class II	Active
Leksell Stereotactic System	13012710	FDA UDI	Class II	Active
Leksell Stereotactic System	1003682	FDA UDI	Class II	Active
Leksell Gamma Knife C 4 4C	1500111	FDA UDI	Class II	Active
Leksell Vantage Stereotactic System	1098528	FDA UDI	Class II	Active
Leksell Stereotactic System	1003681	FDA UDI	Class II	Active
Leksell Vantage Stereotactic System	1072931	FDA UDI	Class II	Active
Leksell Stereotactic System	709669	FDA UDI	Class II	Active
Leksell Stereotactic System Neurosurgical Instruments	1020176	FDA UDI	Class II	Active
Leksell Stereotactic System	1002115	FDA UDI	Class II	Active
Leksell Gamma Knife Perfexion	1001182	FDA UDI	Class II	Active
Leksell Stereotactic System Neurosurgical Instruments	60380-01	FDA UDI	Class II	Active
Leksell Stereotactic System	1004820	FDA UDI	Class II	Active
Leksell Stereotactic System	1003960	FDA UDI	Class II	Active
Leksell Stereotactic System	1000689	FDA UDI	Class II	Active
Leksell Stereotactic System	1003675	FDA UDI	Class II	Active
Leksell Stereotactic System	307031	FDA UDI	Class II	Active
Leksell Vantage Stereotactic System	1051788	FDA UDI	Class II	Active
Leksell Stereotactic System	714973	FDA UDI	Class II	Active
Leksell Stereotactic System	1530041	FDA UDI	Class II	Active
Leksell Gamma Knife Icon	1528948	FDA UDI	Class II	Active
Leksell Stereotactic System Neurosurgical Instruments	60081-32	FDA UDI	Class II	Active
Leksell Stereotactic System	707481	FDA UDI	Class II	Active
Leksell Vantage Stereotactic System	1523232	FDA UDI	Class II	Active
Leksell Stereotactic System	1003838	FDA UDI	Class II	Active
Leksell Stereotactic System	1003676	FDA UDI	Class II	Active
Leksell Stereotactic System	717489	FDA UDI	Class II	Active
Leksell Stereotactic System	A0401-15	FDA UDI	Class II	Active
Leksell Stereotactic System	917171	FDA UDI	Class II	Active
Leksell Stereotactic System Neurosurgical Instruments	50398-01	FDA UDI	Class II	Active
Leksell Stereotactic System	1021148	FDA UDI	Class II	Active
Leksell Stereotactic System	13012540	FDA UDI	Class II	Active
Leksell Stereotactic System	814933	FDA UDI	Class II	Active
Leksell Vantage Stereotactic System	1564185	FDA UDI	Class II	Active

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