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510(k) Data Aggregation
K Number
K213128Device Name
IntraOp VSP Software Device
Manufacturer
Date Cleared
2022-10-21
(389 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Xironetic, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
IntraOp VSP is a software device that is indicated for use with an augmented display which allows for visualization and orientation of 3D digital models of selected structures of a patient's anatomy.
IntraOpVSP is intended to supplement conventional Virtual Surgical Planning (VSP) by facilitating perception of the shape and scale of a patient's anatomical targets for use in preoperative planning and heads-up 3D visualization during surgery.
IntraOpVSP is not intended to provide diagnosis or to guide surgical instrumentation. It is not to be used for stereotactic procedures or surgical navigation.
IntraOpVSP is intended for use by surgeons who have been trained to operate IntraOpVSP software is designed for use with performance-tested hardware specified in the User Manual.
Device Description
IntraOpVSP software displays 3D objects as holograms to inform the user on operative planning. It includes functions for 3D object spatial manipulation and orientation. IntraOpVSP software provides additional information to the surgeon by displaying holograms of the surgical plan, anatomical structures, and guides.
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