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510(k) Data Aggregation
K Number
K111226Device Name
ENDOSCOUT TRACKING SYSTEM
Manufacturer
Date Cleared
2011-07-01
(60 days)
Product Code
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
ROBIN MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The EndoScout is intended to provide physicians and surgeons with the means to track a device during MRI-quided interventional procedures. The EndoScout provides in realtime the position (location and orientation) of the device during MR scanning. This data enables the users to guide an interventional procedure to a target inside the body, using minimal invasive approach.
Devices and tools to be tracked may include: diagnostic devices (e.g. biopsy needles, aspiration needles), therapeutic devices (including devices used to destroy tissue, like RF ablation, laser ablation or cryo-therapy probes, or devices used to deliver therapeutic agents like drugs, chemotherapy agents, genetic vectors, stem cells, etc.) and various support tools (e.g. suction tips, pointers).
Device Description
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K Number
K033485Device Name
ENDOSCOUT
Manufacturer
Date Cleared
2004-04-20
(168 days)
Product Code
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
ROBIN MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The EndoScout is intended to provide physicians and surgeons with the means to track a device during MRF-guided interventional procedures. The EndoScout provides in real time the position (location and orientation) of the entire device during MR scanning inside the body, using minimal invasive approach.
Devices and tools to be tracked may include: diagnostic devices (e.g. biopsy needles, aspiration needles), therapeutic devices used to destroy tissue, like RF ablation, fasci ablation or cryo-therapy probes, or devices used to deliver various substances (e.g. drugs, genetic vectors, stem cells, etc.) and various support tools (e.g. suction tips, pointers).
Device Description
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