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510(k) Data Aggregation
Device Name
Primevision 3DManufacturer
Date Cleared
2026-02-05
(57 days)
Product Code
Regulation Number
892.1750Type
TraditionalPanel
RadiologyAge Range
N/A
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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