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	917830	FDA UDI	Class II	Active
Leksell Stereotactic System Neurosurgical Instruments	1018432	FDA UDI	Class II	Active
Leksell Gamma Knife Perfexion/Icon	1005164	FDA UDI	Class II	Active
Leksell Stereotactic System	717485	FDA UDI	Class II	Active
Leksell Stereotactic System	1001015	FDA UDI	Class II	Active
Leksell Stereotactic System Neurosurgical Instruments	1018439	FDA UDI	Class II	Active
Leksell Gamma Knife Perfexion/Icon	1002491	FDA UDI	Class II	Active
Leksell Stereotactic System	13012690	FDA UDI	Class II	Active
Extend Frame system	1018667	FDA UDI	Class II	Unknown
Leksell Stereotactic System	917831	FDA UDI	Class II	Active
Leksell Stereotactic System Neurosurgical Instruments	A2200-01	FDA UDI	Class II	Active
Leksell Stereotactic System	1000559	FDA UDI	Class II	Active
Extend Frame system	1009632	FDA UDI	Class II	Unknown
Leksell Stereotactic System	1020654	FDA UDI	Class II	Active
Leksell Gamma Knife Perfexion/Icon	1018569	FDA UDI	Class II	Active
Leksell Stereotactic System	60725-01	FDA UDI	Class II	Active
Leksell Stereotactic System	13012670	FDA UDI	Class II	Active
Leksell Vantage Stereotactic System	1072447	FDA UDI	Class II	Active
Leksell Stereotactic System	1003688	FDA UDI	Class II	Active
Leksell Stereotactic System	709674	FDA UDI	Class II	Active
Leksell Stereotactic System	1000579	FDA UDI	Class II	Active
Leksell Stereotactic System Neurosurgical Instruments	60081-40	FDA UDI	Class II	Active
Leksell Stereotactic System	709667	FDA UDI	Class II	Active
Leksell Vantage Stereotactic System	1098532	FDA UDI	Class II	Active
Leksell Vantage Stereotactic System	1527113	FDA UDI	Class II	Active
Leksell Stereotactic System	811105	FDA UDI	Class II	Active
Leksell Vantage Stereotactic System	1055256	FDA UDI	Class II	Active
Leksell Vantage Stereotactic System	1054250	FDA UDI	Class II	Active
Leksell Stereotactic System	1000487	FDA UDI	Class II	Active
Extend Frame system	1013559	FDA UDI	Class II	Unknown
Leksell Stereotactic System	A0420-10	FDA UDI	Class II	Active
Leksell Stereotactic System Neurosurgical Instruments	A2800-15	FDA UDI	Class II	Active
Leksell Stereotactic System	1006743	FDA UDI	Class II	Active
Leksell Stereotactic System	1003684	FDA UDI	Class II	Active
Leksell Stereotactic System	1003951	FDA UDI	Class II	Active
Leksell Stereotactic System	1000699	FDA UDI	Class II	Active
Leksell Stereotactic System	709672	FDA UDI	Class II	Active
Leksell Vantage Stereotactic System	1051632	FDA UDI	Class II	Active
Leksell Stereotactic System Neurosurgical Instruments	1018425	FDA UDI	Class II	Active
Leksell Stereotactic System Neurosurgical Instruments	1024398	FDA UDI	Class II	Active
Leksell Stereotactic System	1004312	FDA UDI	Class II	Active
Leksell Stereotactic System	1000575	FDA UDI	Class II	Active
Leksell Stereotactic System	A0420-26	FDA UDI	Class II	Active
Leksell Stereotactic System	709675	FDA UDI	Class II	Active
Leksell Stereotactic System	1023815	FDA UDI	Class II	Active
Leksell Stereotactic System	13012550	FDA UDI	Class II	Active
Leksell Stereotactic System	1004083	FDA UDI	Class II	Active
Leksell Stereotactic System	1007283	FDA UDI	Class II	Active
Leksell Stereotactic System	716252	FDA UDI	Class II	Active
Leksell Stereotactic System Neurosurgical Instruments	1522155	FDA UDI	Class II	Active

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