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510(k) Data Aggregation
K Number
DEN020001Device Name
BREASTVIEW VISUAL MAPPING SYSTEMManufacturer
Date Cleared
2003-01-31
(248 days)
Product Code
Regulation Number
884.2990Type
Post-NSEReference & 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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