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K Number
K010641

Validate with FDA (Live)

Device Name
GE CT-PET SYSTEM
Manufacturer
GE MEDICAL SYSTEMS, INC.
Date Cleared
2001-03-30

(25 days)

Product Code
JAK
Regulation Number
892.1750
Type
Traditional
Panel
Radiology
Age Range
N/A
Reference & Predicate Devices
N/A
Predicate For
K013521,K022872,K023014,K023988,K042257
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

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N/A