Epica International has announced an updated 510(k) clearance from the US Food and Drug Administration (FDA) for its See Factor CT3 System.
This clearance signifies enhancements to the device, expanding its clinical applications and mobility.
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The See Factor CT3 offers high-resolution imaging and multi-modality capabilities and allows for CT, fluoroscopy, and digital radiography in various clinical settings.
Epica said the updated clearance reflects the system’s significant improvements since its initial 2019 release.
The system is now equipped with an indexing gantry that provides high-resolution, orthogonal, and three-dimensional CT images for a wide range of clinical applications.
Featuring advanced imaging technology, the See Factor CT3 allows clinicians to perform computed tomography, fluoroscopy and digital radiography in any suitably shielded location, thus avoiding the need to move patients.
The system’s onboard DICOM viewer allows for immediate image review by the treating physician, streamlining the diagnostic and treatment process.
The See Factor CT3 is designed for acquiring detailed head, neck, and limb images in adult patients. It can also capture images of parts of the spine, thorax and pelvic bones, with a particular focus on areas with high X-ray attenuation such as bony structures.
Additionally, the device features a 62.5cm gantry bore and a 30cm field of view, providing 2D and 3D imaging for both intra-operative and clinical use.
Key features of the See Factor CT3 System include high-resolution imaging with clarity down to 0.1mm (100 microns), ensuring precise diagnostics. Its mobility eliminates the need for extensive infrastructure typically required for large, fixed scanning equipment.
The system’s multi-modal capabilities integrate various imaging modalities into one platform.
Featuring a user-friendly interface, the device has a compact and versatile design and is suitable for various clinical environments.
