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K Number
K941823
Device Name
LEKSELL NEURO GENERATOR AND ACCESSORIES
Manufacturer
ELEKTA INSTRUMENTS, INC.
Date Cleared
1996-03-22

(709 days)

Product Code
GXD
Regulation Number
882.4400
Type
Traditional
Panel
NE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 882.4400 Radiofrequency lesion generator.

(a)
Identification. A radiofrequency lesion generator is a device used to produce lesions in the nervous system or other tissue by the direct application of radiofrequency currents to selected sites.(b)
Classification. Class II (performance standards).