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 Neurosurgical Instruments	307165	FDA UDI	Class II	Active
Leksell Stereotactic System	1003531	FDA UDI	Class II	Active
Leksell Vantage Stereotactic System	1055506	FDA UDI	Class II	Active
Leksell Stereotactic System	60136-01	FDA UDI	Class II	Active
Leksell Stereotactic System	707479	FDA UDI	Class II	Active
Leksell Stereotactic System	1530039	FDA UDI	Class II	Active
Extend Frame system	1526879	FDA UDI	Class II	Unknown
Leksell Vantage Stereotactic System	1055007	FDA UDI	Class II	Active
Leksell Stereotactic System	1003678	FDA UDI	Class II	Active
Leksell Stereotactic System	60300-01	FDA UDI	Class II	Active
Leksell Stereotactic System	104522	FDA UDI	Class II	Active
Leksell Stereotactic System Neurosurgical Instruments	50386-01	FDA UDI	Class II	Active
Leksell Stereotactic System	1014150	FDA UDI	Class II	Active
Leksell Stereotactic System	1000075	FDA UDI	Class II	Active
Leksell Gamma Knife Perfexion/Icon	A0202-02	FDA UDI	Class II	Active
Leksell Stereotactic System Neurosurgical Instruments	60080-40	FDA UDI	Class II	Active
Leksell Stereotactic System	A0420-24	FDA UDI	Class II	Active
Leksell Stereotactic System	707478	FDA UDI	Class II	Active
Leksell Stereotactic System	1002031	FDA UDI	Class II	Active
Leksell Stereotactic System Neurosurgical Instruments	50389-01	FDA UDI	Class II	Active
Leksell Vantage Stereotactic System	1054956	FDA UDI	Class II	Active
Leksell Stereotactic System	402191	FDA UDI	Class II	Active
Leksell Gamma Knife Icon	1539744	FDA UDI	Class II	Active
Leksell Stereotactic System Neurosurgical Instruments	907801	FDA UDI	Class II	Active
Leksell Stereotactic System	13012660	FDA UDI	Class II	Active
Leksell Vantage Stereotactic System	1054773	FDA UDI	Class II	Active
Leksell Stereotactic System Neurosurgical Instruments	1018446	FDA UDI	Class II	Active
Leksell Vantage Stereotactic System	1054850	FDA UDI	Class II	Active
Leksell Stereotactic System	712059	FDA UDI	Class II	Active
Leksell Stereotactic System	1002248	FDA UDI	Class II	Active
Leksell Gamma Knife Perfexion/Icon	1005926	FDA UDI	Class II	Active
Leksell Stereotactic System	1002044	FDA UDI	Class II	Unknown
Extend Frame system	1526861	FDA UDI	Class II	Unknown
Leksell GammaPlan	1529604	FDA UDI	Class II	Unknown
Leksell Stereotactic System	707482	FDA UDI	Class II	Active
Leksell Vantage Stereotactic System	1519676	FDA UDI	Class II	Active
Leksell Stereotactic System	302195	FDA UDI	Class II	Active
Leksell Stereotactic System	1014413	FDA UDI	Class II	Active
Leksell Stereotactic System	A0440-02	FDA UDI	Class II	Active
Leksell Stereotactic System Neurosurgical Instruments	912465	FDA UDI	Class II	Active
Leksell Stereotactic System	916282	FDA UDI	Class II	Active
Leksell Stereotactic System	402192	FDA UDI	Class II	Active
Leksell Stereotactic System	1016899	FDA UDI	Class II	Active
Extend Frame system	1509087	FDA UDI	Class II	Unknown
Leksell Stereotactic System	1003533	FDA UDI	Class II	Active
Leksell Stereotactic System	13012590	FDA UDI	Class II	Active
Leksell Stereotactic System	404890	FDA UDI	Class II	Active
Extend Frame system	1526875	FDA UDI	Class II	Unknown
Leksell Stereotactic System Neurosurgical Instruments	1020177	FDA UDI	Class II	Active
Leksell Stereotactic System	12004601	FDA UDI	Class II	Active

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