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K Number
K010968

Validate with FDA (Live)

Device Name
VECTORVISION CT/FLUORO
Manufacturer
BRAINLAB, AG
Date Cleared
2001-08-30

(150 days)

Product Code
HAW
Regulation Number
882.4560
Type
Traditional
Panel
Neurology
Age Range
N/A
Reference & Predicate Devices
N/A
Predicate For
K024192,K033413,K042721,K053159
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

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§ 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).