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510(k) Data Aggregation
K Number
K945957Device Name
AUSONICS OPUS 2 REALTIME ULTRASOUND SCANNERManufacturer
Date Cleared
1996-04-15
(496 days)
Regulation Number
892.1550Type
TraditionalPanel
RadiologyReference & Predicate Devices
N/A
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Device Name :
AUSONICS OPUS 2 REALTIME ULTRASOUND SCANNER
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
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AI/ML Overview
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