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510(k) Data Aggregation
K Number
K162314Device Name
IMACTIS CT-Navigation system
Manufacturer
Date Cleared
2018-04-24
(614 days)
Product Code
Regulation Number
892.1750Why did this record match?
Applicant Name (Manufacturer) :
IMACTIS, SAS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The IMACTIS® CT-NAVIGATION system is used with linear instruments including but not limited to biopsy needle, aspiration needle, anesthesia needle, ablation needle.
The system supports a workflow based on automated image registration of spatial mapping from image space to physical space.
The system is intended for intra-operative guidance during percutaneous interventional procedure. It is intended for use by trained physicians in clinical intervention and for structures where is currently used for visualizing such procedures.
The system is not intended for guidance for the head, nervous system and central circulatory system (heart included).
Device Description
The IMACTIS® CT-NAVIGATION system consists of a navigation station, specific software and a dedicated instrumentation set used in an interventional radiology room during percutaneous interventional radiological procedures performed under Computed Tomography.
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