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K Number
K010336

Validate with FDA (Live)

Device Name
ADVANTAGE WINDOWS CT/PET FUSION
Manufacturer
GE MEDICAL SYSTEMS, INC.
Date Cleared
2001-02-16

(11 days)

Product Code
LLZ
Regulation Number
892.2050
Type
Traditional
Panel
Radiology
Age Range
N/A
Reference & Predicate Devices
N/A
Predicate For
K020546,K022310,K041484,K052345,K061370,K070248,K081076,K093234,K100881
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

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N/A