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510(k) Data Aggregation
K Number
K120300Device Name
CT-GUIDE NEEDLE GUIDANCE SYSTEM
Manufacturer
ACTIVIEWS LTD
Date Cleared
2012-04-13
(73 days)
Product Code
JAK
Regulation Number
892.1750Why did this record match?
Applicant Name (Manufacturer) :
ACTIVIEWS LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CT-Guide is a stereotactic accessory for Computed Tomography ("CT") systems. The CT-Guide displays an interventional instrument on a computer monitor that also displays a CT-based model of the target organ(s).
The CT-Guide is intended to be used in clinical interventions in the lung and liver, where CT is currently used for visualizing such procedures.
Device Description
The CT-Guide System is comprised of four main components: (1) the ActiSensor, a disposable video camera that is mounted onto a holder, which is clipped to a needle; (2) the ActiSticker, a disposable pad, which provides visual and radio-opaque reference markers; (3) a workstation that contains a dedicated computer; and (4) accompanying computer software.
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K Number
K113063Device Name
CT-GUIDE NEEDLE GUIDANCE SYSTEM
Manufacturer
ACTIVIEWS LTD
Date Cleared
2011-11-10
(27 days)
Product Code
JAK
Regulation Number
892.1750Why did this record match?
Applicant Name (Manufacturer) :
ACTIVIEWS LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CT-Guide is a stereotactic accessory for Computed Tomography ("CT") systems. The CT-Guide displays an interventional instrument on a computer monitor that also displays a CT-based model of the target organ(s).
The CT-Guide is intended to be used in clinical interventions in the lung, where CT is currently used for visualizing such procedures.
Device Description
The CT-Guide System is comprised of four main components: (1) the ActiSensor, a disposable video camera that is mounted onto a holder, which is clipped to a needle: (2) the ActiSticker, a disposable pad, which provides visual and radio-opaque reference markers; (3) a workstation that contains a dedicated computer; and (4) accompanying computer software.
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K Number
K110812Device Name
CT-GUIDE NEEDLE GUIDANCE SYSTEM
Manufacturer
ACTIVIEWS LTD
Date Cleared
2011-06-21
(90 days)
Product Code
JAK
Regulation Number
892.1750Why did this record match?
Applicant Name (Manufacturer) :
ACTIVIEWS LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CT-Guide is a stereotactic accessory for Computed Tomography ("CT") systems. The CT-Guide displays an interventional instrument on a computer monitor that also displays a CT-based model of the target organ(s).
The CT-Guide is intended to be used in clinical interventions in the lung, where CT is currently used for visualizing such procedures.
Device Description
The CT-Guide System is comprised of four main components: (1) the ActiSensor, a disposable video camera that is mounted onto a holder, which is clipped to a needle; (2) the ActiSticker, a disposable pad, which provides visual and radio-opaque reference markers; (3) a workstation that contains a dedicated computer; and (4) accompanying computer software.
Ask a Question
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