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510(k) Data Aggregation
K Number
K961002Device Name
DIASONICS ITNRAOPERATIVE PROBESManufacturer
Date Cleared
1997-01-22
(316 days)
Product Code
Regulation Number
892.1570Type
TraditionalPanel
RadiologyReference & Predicate Devices
N/A
Predicate For
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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K Number
K951998Manufacturer
Date Cleared
1996-03-27
(334 days)
Product Code
Regulation Number
892.1550Type
TraditionalPanel
RadiologyReference & Predicate Devices
N/A
Predicate For
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
Ask a Question
Ask a specific question about this device
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