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510(k) Data Aggregation
K Number
K232339Device Name
Augmented Reality Application
Manufacturer
Date Cleared
2024-02-01
(181 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Sira Medical, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Sira Medical Augmented Reality Application is intended as a medical imaging system that allows the processing, review, analysis, and communication of augmented reality images acquired from the same data used to generate conventional CT scans and MRIs. Sira Medical software is designed for preoperative surgical planning and intended to be used by trained and qualified clinicians who are responsible for making patient management decisions.
Device Description
The Sira Medical Augmented Reality Application is used for viewing and manipulating 3D models created by the Sira 3D Image Preparation Service from customer-supplied anonymized (de-identified) imaging in Augmented Reality (AR) on a Head Mounted Display (HMD). The application allows the user to manipulate one or more 3D models in real time in an Augmented Reality (AR) environment. The user can view the model, adjust the orientation, scale, rotate and position the models within the AR visual space. Models can be sliced to create separate objects or merged together to create a single object. These models are used for preoperative surgical planning but are not used intraoperatively (during surgical procedures).
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