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510(k) Data Aggregation
K Number
K011457Device Name
ALOKA SSD-5500 WITH KI AND A-SMAManufacturer
Date Cleared
2001-05-23
(12 days)
Product Code
Regulation Number
892.1550Type
TraditionalPanel
RadiologyReference & Predicate Devices
N/A
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Device Name :
ALOKA SSD-5500 WITH KI AND A-SMA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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