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Found 2 results
510(k) Data Aggregation
K Number
K010850Device Name
POLESTAR N-10Manufacturer
Date Cleared
2001-12-17
(271 days)
Product Code
Regulation Number
892.1000Type
TraditionalPanel
RadiologyReference & Predicate Devices
N/A
Predicate For
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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K Number
K002242Device Name
POLESTAR N-10Manufacturer
Date Cleared
2000-09-20
(58 days)
Product Code
Regulation Number
892.1000Type
TraditionalPanel
RadiologyReference & Predicate Devices
N/A
Predicate For
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
Ask a Question
Ask a specific question about this device
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