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	1054775	FDA UDI	Class II	Active
Extend Frame system	1017324	FDA UDI	Class II	Unknown
Leksell Stereotactic System	1001176	FDA UDI	Class II	Active
Leksell Stereotactic System	402189	FDA UDI	Class II	Active
Leksell Stereotactic System Neurosurgical Instruments	911761	FDA UDI	Class II	Active
Extend Frame system	1017450	FDA UDI	Class II	Unknown
Leksell Stereotactic System Neurosurgical Instruments	1020173	FDA UDI	Class II	Active
Leksell Stereotactic System	1003958	FDA UDI	Class II	Active
Leksell Stereotactic System	1001184	FDA UDI	Class II	Active
Leksell Stereotactic System	13012570	FDA UDI	Class II	Active
Leksell Stereotactic System	1003534	FDA UDI	Class II	Active
Leksell Stereotactic System	1004081	FDA UDI	Class II	Active
Leksell Stereotactic System	13004630	FDA UDI	Class II	Active
Leksell Stereotactic System	A0860-04	FDA UDI	Class II	Active
Leksell Stereotactic System	1006584	FDA UDI	Class II	Active
Leksell Stereotactic System	A1200-04	FDA UDI	Class II	Active
Leksell Stereotactic System Neurosurgical Instruments	60377-01	FDA UDI	Class II	Active
Leksell Gamma Knife Perfexion/Icon	1002942	FDA UDI	Class II	Active
Leksell Stereotactic System Neurosurgical Instruments	1018442	FDA UDI	Class II	Active
Extend Frame system	1526866	FDA UDI	Class II	Unknown
Extend Frame system	1526868	FDA UDI	Class II	Unknown
Leksell Stereotactic System	1530036	FDA UDI	Class II	Active
Leksell Stereotactic System	1530038	FDA UDI	Class II	Active
Leksell Stereotactic System Neurosurgical Instruments	60080-25	FDA UDI	Class II	Active
Leksell Stereotactic System	1003957	FDA UDI	Class II	Active
Leksell Stereotactic System	709668	FDA UDI	Class II	Active
Leksell Stereotactic System	1000705	FDA UDI	Class II	Active
Leksell Vantage Stereotactic System	1072922	FDA UDI	Class II	Active
Leksell Stereotactic System Neurosurgical Instruments	1522153	FDA UDI	Class II	Active
Leksell Stereotactic System	1000116	FDA UDI	Class II	Active
Leksell Stereotactic System	1003686	FDA UDI	Class II	Active
Extend Frame system	1019178	FDA UDI	Class II	Unknown
Leksell Stereotactic System Neurosurgical Instruments	1024404	FDA UDI	Class II	Active
Leksell Vantage Stereotactic System	1536894	FDA UDI	Class II	Active
Leksell GammaPlan	1529980	FDA UDI	Class II	Active
Leksell Stereotactic System	1000582	FDA UDI	Class II	Active
Leksell Stereotactic System Neurosurgical Instruments	1024401	FDA UDI	Class II	Active
Leksell Vantage Stereotactic System	1519674	FDA UDI	Class II	Active
Leksell Stereotactic System	709671	FDA UDI	Class II	Active
Leksell Stereotactic System	60361-01	FDA UDI	Class II	Active
Extend Frame system	1024366	FDA UDI	Class II	Unknown
Leksell Gamma Knife Perfexion/Icon	A0202-04	FDA UDI	Class II	Active
Leksell Stereotactic System	709676	FDA UDI	Class II	Active
Leksell Gamma Knife Icon	1526778	FDA UDI	Class II	Active
Leksell Stereotactic System	407010	FDA UDI	Class II	Active
Leksell Stereotactic System	912965	FDA UDI	Class II	Active
Leksell Stereotactic System	13012700	FDA UDI	Class II	Active
Leksell Stereotactic System	1003680	FDA UDI	Class II	Active
Leksell Gamma Knife Perfexion/Icon	1057878	FDA UDI	Class II	Active
Leksell Stereotactic System Neurosurgical Instruments	1505536	FDA UDI	Class II	Active

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