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 Gamma Knife Icon	1075251	FDA UDI	Class II	Active
Leksell Vantage Stereotactic System	1053958	FDA UDI	Class II	Active
Leksell Stereotactic System	A0420-29	FDA UDI	Class II	Active
Leksell Stereotactic System	1000349	FDA UDI	Class II	Active
Leksell Stereotactic System Neurosurgical Instruments	1506444	FDA UDI	Class II	Active
Leksell Vantage Stereotactic System	1051796	FDA UDI	Class II	Active
Leksell Vantage Stereotactic System	1102873	FDA UDI	Class II	Active
Leksell Vantage Stereotactic System	1060488	FDA UDI	Class II	Active
Leksell Stereotactic System	1003594	FDA UDI	Class II	Active
Extend Frame system	1011049	FDA UDI	Class II	Unknown
Leksell Stereotactic System	1530040	FDA UDI	Class II	Active
Leksell Stereotactic System	13012560	FDA UDI	Class II	Active
Leksell Stereotactic System	1003683	FDA UDI	Class II	Active
Leksell Stereotactic System	302197	FDA UDI	Class II	Active
Leksell Vantage Stereotactic System	1051623	FDA UDI	Class II	Active
Leksell Stereotactic System	60082-05	FDA UDI	Class II	Active
Leksell Vantage Stereotactic System	1519675	FDA UDI	Class II	Active
Leksell Vantage Stereotactic System	1051800	FDA UDI	Class II	Active
Leksell Stereotactic System	918238	FDA UDI	Class II	Active
Extend Frame system	1009630	FDA UDI	Class II	Unknown
Leksell Gamma Knife Icon	1526777	FDA UDI	Class II	Active
Leksell Stereotactic System	13012650	FDA UDI	Class II	Active
Leksell Stereotactic System	1002964	FDA UDI	Class II	Active
Leksell Stereotactic System Neurosurgical Instruments	1018428	FDA UDI	Class II	Active
Leksell Stereotactic System	50695-01	FDA UDI	Class II	Active
Leksell Vantage Stereotactic System	1054879	FDA UDI	Class II	Active
Leksell Stereotactic System	1003949	FDA UDI	Class II	Active
Leksell Stereotactic System	917119	FDA UDI	Class II	Active
Leksell Stereotactic System	404889	FDA UDI	Class II	Active
Leksell Vantage Stereotactic System	1051338	FDA UDI	Class II	Active
Leksell Stereotactic System Neurosurgical Instruments	50376-01	FDA UDI	Class II	Active
Leksell Stereotactic System	1002136	FDA UDI	Class II	Active
Leksell Gamma Knife Perfexion/Icon	1005306	FDA UDI	Class II	Active
Leksell Stereotactic System	1003689	FDA UDI	Class II	Active
Leksell Vantage Stereotactic System	1053930	FDA UDI	Class II	Active
Leksell Stereotactic System	1000810	FDA UDI	Class II	Active
Leksell Stereotactic System	A0227-04	FDA UDI	Class II	Active
Leksell Stereotactic System	707483	FDA UDI	Class II	Active
Leksell Vantage Stereotactic System	1054768	FDA UDI	Class II	Active
Leksell Stereotactic System	1006748	FDA UDI	Class II	Active
Leksell Stereotactic System	13012730	FDA UDI	Class II	Active
Leksell Vantage Stereotactic System	1054253	FDA UDI	Class II	Active
Extend Frame system	1526874	FDA UDI	Class II	Unknown
Leksell Vantage Stereotactic System	1055045	FDA UDI	Class II	Active
Leksell Stereotactic System	1003593	FDA UDI	Class II	Active
Leksell Stereotactic System Neurosurgical Instruments	60080-21	FDA UDI	Class II	Active
Leksell Stereotactic System Neurosurgical Instruments	1018449	FDA UDI	Class II	Active
Leksell Stereotactic System Neurosurgical Instruments	A2430-01	FDA UDI	Class II	Active
Leksell Stereotactic System Neurosurgical Instruments	60379-01	FDA UDI	Class II	Active
Leksell Gamma Knife Perfexion/Icon	1002637	FDA UDI	Class II	Active

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