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510(k) Data Aggregation
K Number
DEN240074Device Name
Pulsenmore ESManufacturer
Date Cleared
2025-10-31
(324 days)
Product Code
Regulation Number
N/AType
DirectPanel
RadiologyReference & Predicate Devices
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Predicate For
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K Number
K252074Manufacturer
Date Cleared
2025-10-31
(121 days)
Regulation Number
892.1550Type
TraditionalPanel
RadiologyReference & Predicate Devices
N/A
Predicate For
N/A
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K Number
K250337Device Name
AiORTA - PlanManufacturer
Date Cleared
2025-10-30
(266 days)
Product Code
Regulation Number
892.2050Type
TraditionalPanel
RadiologyReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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K Number
K251985Device Name
LOGIQ E10Date Cleared
2025-10-29
(124 days)
Regulation Number
892.1550Type
TraditionalPanel
RadiologyReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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K Number
K253242Device Name
LCD Monitor (C1216W, C822W, C821W)Manufacturer
Date Cleared
2025-10-29
(30 days)
Product Code
Regulation Number
892.2050Type
SpecialPanel
RadiologyReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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K Number
K251963Device Name
LOGIQ E10sDate Cleared
2025-10-29
(125 days)
Regulation Number
892.1550Type
TraditionalPanel
RadiologyReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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K Number
K252547Device Name
TheraSphere 360 Y-90 Management PlatformManufacturer
Date Cleared
2025-10-28
(77 days)
Product Code
Regulation Number
892.2050Type
TraditionalPanel
RadiologyReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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K Number
K251027Device Name
cvi42 Coronary Plaque Software ApplicationManufacturer
Date Cleared
2025-10-27
(208 days)
Product Code
Regulation Number
892.2050Type
TraditionalPanel
RadiologyReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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K Number
K251827Device Name
Azurion R3.1Manufacturer
Date Cleared
2025-10-24
(133 days)
Product Code
Regulation Number
892.1650Type
TraditionalPanel
RadiologyReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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K Number
K251059Device Name
Syngo Carbon Clinicals (VA41)Manufacturer
Date Cleared
2025-10-24
(203 days)
Regulation Number
892.2050Type
TraditionalPanel
RadiologyReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
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