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510(k) Data Aggregation
K Number
K210344Device Name
inVisionOS
Manufacturer
Date Cleared
2021-11-10
(278 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
PrecisionOS Technology Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
inVisionOS is a software-based medical image viewing system intended for use as a software interface for the preoperative evaluation of surgical treatment options of bone pathologies imaged using CT scans.
Device Description
inVisionOS is a software-based pre-surgical planning system with a virtual reality (VR) headset. It is intended as pre-operative planning software for the evaluation of orthopedic surgical treatment options. The inVisionOS software displays virtual reality 3D models of patient data by uploading and converting Computed Tomography (CT) data into a 3-Dimensional (3D) format to be used with a virtual reality (VR) headset. It provides the user with the ability to manipulate the 3D model from multiple points of view through translation, rotation, and scaling. The user can position the Slice Plane Tool in the sagittal, coronal, axial, and oblique planes over the 3D model. This permits the user to view a CT-based 2D image at intersecting points along the plane. The inVisionOS software with a VR headset and controllers is not intended for use during surgery. The inVisionOS software is not intended to be used for diagnosis.
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