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K Number
K024201
Device Name
NAVIGUS FIDUCIAL MARKER SYSTEM, MODELS FM-1000, FM-2000
Manufacturer
IMAGE-GUIDED NEUROLOGICS, INC.
Date Cleared
2003-03-12

(82 days)

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

The Navigus Fiducial Marker System is intended to provide fixed reference point(s) in patients requiring stereotactic provide The device is provided sterile and is for one time use only.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for the Navigus Fiducial Marker System. It confirms the substantial equivalence of the device to a predicate device and allows it to be marketed, but it does not contain the detailed study information (acceptance criteria, reported performance, sample sizes, ground truth, etc.) that you are requesting.

The letter focuses on regulatory approval and compliance, not the technical study results. Therefore, I cannot extract the specific information you asked for based on this document.

§ 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).