K Number
K003238Device Name
SOLID STATE X-RAY IMAGING DEVICESManufacturer
Date Cleared
2001-10-01
(349 days)
Product Code
Regulation Number
892.1680Type
TraditionalPanel
RadiologyReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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N/A