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	712060	FDA UDI	Class II	Active
Leksell Stereotactic System	1000351	FDA UDI	Class II	Active
Leksell GammaPlan	1551287	FDA UDI	Class II	Active
Leksell Stereotactic System	1003530	FDA UDI	Class II	Active
Leksell Stereotactic System	402188	FDA UDI	Class II	Active
Leksell Stereotactic System	50152-04	FDA UDI	Class II	Active
Leksell Stereotactic System	A0420-30	FDA UDI	Class II	Unknown
Leksell Stereotactic System	1002678	FDA UDI	Class II	Active
Leksell Stereotactic System	1006581	FDA UDI	Class II	Active
Leksell Stereotactic System	911337	FDA UDI	Class II	Active
Leksell Stereotactic System	1006749	FDA UDI	Class II	Active
Leksell Stereotactic System	1000704	FDA UDI	Class II	Active
Extend Frame system	1051520	FDA UDI	Class II	Unknown
Leksell Gamma Knife Icon	1524411	FDA UDI	Class II	Unknown
Leksell Stereotactic System	1003965	FDA UDI	Class II	Active
Leksell Vantage Stereotactic System	1519673	FDA UDI	Class II	Active
Leksell Stereotactic System	1003677	FDA UDI	Class II	Active
Leksell Stereotactic System Neurosurgical Instruments	60080-35	FDA UDI	Class II	Active
Leksell Vantage Stereotactic System	1551581	FDA UDI	Class II	Active
Leksell Stereotactic System	1000566	FDA UDI	Class II	Active
Leksell Stereotactic System	1000598	FDA UDI	Class II	Active
Leksell Stereotactic System	1003687	FDA UDI	Class II	Active
Leksell Stereotactic System	1000560	FDA UDI	Class II	Active
Leksell Vantage Stereotactic System	1053444	FDA UDI	Class II	Active
Leksell Stereotactic System	13012620	FDA UDI	Class II	Active
Leksell Stereotactic System	1006559	FDA UDI	Class II	Active
Leksell Vantage Stereotactic System	1053704	FDA UDI	Class II	Active
Leksell Stereotactic System Neurosurgical Instruments	14001050	FDA UDI	Class II	Active
Leksell Stereotactic System	1028779	FDA UDI	Class II	Active
Leksell Stereotactic System	907999	FDA UDI	Class II	Active
Leksell Stereotactic System	1003685	FDA UDI	Class II	Active
Leksell Stereotactic System Neurosurgical Instruments	60080-32	FDA UDI	Class II	Active
Leksell Gamma Knife Icon	1030370	FDA UDI	Class II	Active
Leksell Stereotactic System Neurosurgical Instruments	1524113	FDA UDI	Class II	Active
Leksell Stereotactic System	1000563	FDA UDI	Class II	Active
Leksell Vantage Stereotactic System	1054774	FDA UDI	Class II	Active
Leksell Stereotactic System	1004082	FDA UDI	Class II	Active
Leksell Stereotactic System	917120	FDA UDI	Class II	Active
Leksell Stereotactic System Neurosurgical Instruments	1505535	FDA UDI	Class II	Active
Leksell Stereotactic System	707480	FDA UDI	Class II	Active
Leksell Vantage Stereotactic System	1098530	FDA UDI	Class II	Active
Leksell Stereotactic System	A0820-07	FDA UDI	Class II	Active
Leksell Stereotactic System	1006745	FDA UDI	Class II	Active
Leksell Stereotactic System	A0202-01	FDA UDI	Class II	Active
Leksell Stereotactic System Neurosurgical Instruments	60379-02	FDA UDI	Class II	Active
Leksell Stereotactic System	707484	FDA UDI	Class II	Active
Leksell Stereotactic System Neurosurgical Instruments	A2800-26	FDA UDI	Class II	Active
Leksell Stereotactic System	402190	FDA UDI	Class II	Active
Leksell Stereotactic System	1000700	FDA UDI	Class II	Active
Leksell Stereotactic System	A0401-05	FDA UDI	Class II	Active

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