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K Number
K000300

Validate with FDA (Live)

Device Name
LIGHTSPEED 2.0CT SCANNER SYSTEM
Manufacturer
GE MEDICAL SYSTEMS, INC.
Date Cleared
2000-02-15

(15 days)

Product Code
JAK
Regulation Number
892.1750
Type
Traditional
Panel
Radiology
Age Range
N/A
Reference & Predicate Devices
N/A
Predicate For
K012836,K023332,K051765,K052855
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

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§ 892.1750 Computed tomography x-ray system.

(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.