SpectoMed (v1.0)
Specto MedicalSpectoMed (v1.0) is a software tool for medical professionals that enables real-time 3D visualization and analysis of CT and MRI images. It supports virtual and augmented reality interfaces to aid clinicians in preoperative planning and during surgery by providing realistic spatial views of patient anatomy along with measurement tools, enhancing diagnostic assessment and surgical preparation.
Intended Use
Provides real-time spatial-visualization of medical imaging allowing manipulation, processing, review, analysis, communication and media interchange of multi-dimensional digital images including CT and MRI datasets. Aids clinicians in preoperative planning and intraoperative display by providing measurements and import of compatible objects within spatial visuals of patient anatomy as an aid for assessing patient images.
Technology
SpectoMed (v1.0) is a software-only device that allows trained medical professionals to review CT and MRI data in 3D and through virtual and augmented reality interfaces via a desktop application or compatible VR/AR headsets. It supports interactive manipulation, filtering, annotations, measurements, and media interchange compliant with DICOM standards, facilitating use in office and operating room settings (non-sterile). It does not register images to patients or operate in sterile fields.
Performance
The device was validated via software verification and validation following recognized standards (ANSI AAMI IEC 62304:2006/A1:2016) and FDA guidance. Measurement performance was tested against a cleared reference device Osirix MD (K101342) using digital phantoms with no statistical differences in distance and angle measurements, confirming safety and effectiveness.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
7/26/2024
5 months - 2
FDA Approval
1/14/2025
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