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K Number
K031999
Device Name
ELEKTA LEKSELL STEREOTACTIC SYSTEM WITH MR POST KIT
Manufacturer
ELEKTA INSTRUMENT AB
Date Cleared
2003-07-25

(28 days)

Product Code
HAW
Regulation Number
882.4560
Type
Special
Panel
RA
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Leksell Stereotactic System with MR post kit is a system intended for localization and diagnosis of intracranial disorders and their surgical treatment, including radiotherapy and stereotactic radiaton therapy

Device Description

Not Found

AI/ML Overview

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) clearance letter from the FDA for the Elekta Leksell Stereotactic System, indicating that the device is substantially equivalent to a predicate device. It defines the indications for use but does not contain details of any performance studies, acceptance criteria, sample sizes, or ground truth establishment.

§ 882.4560 Stereotaxic instrument.

(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).