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K Number
K955253
Device Name
SHIMADZU WHOLE BODY X-RAY SCANNER SCT-7000TH
Manufacturer
SHIMADZU MEDICAL SYSTEMS
Date Cleared
1996-01-26

(74 days)

Product Code
JAK
Regulation Number
892.1750
Type
Traditional
Panel
RA
Reference & Predicate Devices
N/A
Predicate For
K973327
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 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.