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510(k) Data Aggregation
K Number
K011049Device Name
EXPRESSSUITEManufacturer
Date Cleared
2001-10-01
(178 days)
Product Code
Regulation Number
892.2030Type
TraditionalPanel
RadiologyReference & Predicate Devices
N/A
Why did this record match?
Device Name :
EXPRESSSUITE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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