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 Vantage Stereotactic System	1051635	FDA UDI	Class II	Active
Leksell Vantage Stereotactic System	1098534	FDA UDI	Class II	Active
Leksell Stereotactic System	1003948	FDA UDI	Class II	Active
Extend Frame system	1017322	FDA UDI	Class II	Unknown
Leksell Stereotactic System	1006747	FDA UDI	Class II	Active
Leksell Vantage Stereotactic System	1054751	FDA UDI	Class II	Active
Leksell Gamma Knife Icon	1032815	FDA UDI	Class II	Active
Extend Frame system	1526870	FDA UDI	Class II	Unknown
Leksell Stereotactic System	12004590	FDA UDI	Class II	Active
Leksell Stereotactic System	1004084	FDA UDI	Class II	Active
Leksell Stereotactic System Neurosurgical Instruments	1018435	FDA UDI	Class II	Active
Leksell Stereotactic System	A0440-05	FDA UDI	Class II	Active
Leksell Stereotactic System Neurosurgical Instruments	1018452	FDA UDI	Class II	Active
Leksell Vantage Stereotactic System	1054958	FDA UDI	Class II	Active
Leksell Stereotactic System Neurosurgical Instruments	1075647	FDA UDI	Class II	Active
Leksell Stereotactic System	716255	FDA UDI	Class II	Active
Leksell Vantage Stereotactic System	1051631	FDA UDI	Class II	Active
Leksell Gamma Knife Icon	1030401	FDA UDI	Class II	Active
Extend Frame system	1526872	FDA UDI	Class II	Unknown
Leksell Stereotactic System	302196	FDA UDI	Class II	Active
Leksell Stereotactic System	1003670	FDA UDI	Class II	Active
Leksell Stereotactic System	1006472	FDA UDI	Class II	Active
Leksell Vantage Stereotactic System	1072893	FDA UDI	Class II	Active
Leksell Stereotactic System	13012640	FDA UDI	Class II	Active
Leksell Vantage Stereotactic System	1519677	FDA UDI	Class II	Active
Leksell Stereotactic System	13012600	FDA UDI	Class II	Active
Leksell Stereotactic System	917118	FDA UDI	Class II	Active
Leksell Stereotactic System	14010560	FDA UDI	Class II	Active
Leksell Stereotactic System	1013578	FDA UDI	Class II	Active
Leksell Stereotactic System	13012680	FDA UDI	Class II	Active
Extend Frame system	1526877	FDA UDI	Class II	Unknown
Leksell Vantage Stereotactic System	1055507	FDA UDI	Class II	Active
Leksell Stereotactic System	A0440-07	FDA UDI	Class II	Active
Leksell Stereotactic System	302193	FDA UDI	Class II	Active
Leksell Stereotactic System	A0440-01	FDA UDI	Class II	Active
Leksell Stereotactic System Neurosurgical Instruments	911934	FDA UDI	Class II	Active
Leksell Stereotactic System	404888	FDA UDI	Class II	Active
Leksell Stereotactic System	709670	FDA UDI	Class II	Active
Leksell Stereotactic System Neurosurgical Instruments	1524112	FDA UDI	Class II	Active
Extend Frame system	1019183	FDA UDI	Class II	Unknown
Leksell Stereotactic System	1020954	FDA UDI	Class II	Active
Leksell Stereotactic System Neurosurgical Instruments	60081-35	FDA UDI	Class II	Active
Leksell Stereotactic System	814932	FDA UDI	Class II	Active
Leksell Vantage Stereotactic System	1043424	FDA UDI	Class II	Active
Leksell Vantage Stereotactic System	1055306	FDA UDI	Class II	Active
Leksell Stereotactic System	914798	FDA UDI	Class II	Active
Leksell Stereotactic System	1004085	FDA UDI	Class II	Active
Leksell Stereotactic System	1000573	FDA UDI	Class II	Active
Leksell Stereotactic System Neurosurgical Instruments	50378-02	FDA UDI	Class II	Active
Leksell Gamma Knife C 4 4C	1500112	FDA UDI	Class II	Active

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