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510(k) Data Aggregation
K Number
K964288Device Name
CALL-RAD PC TELERADIOLOGYManufacturer
Date Cleared
1997-04-23
(177 days)
Product Code
Regulation Number
892.2030Type
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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