Tuesday, July 16, 2024

See Factor CT3 System by Epica Receives FDA 510(k) Approval

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See factor CT3 system is equipped to allow for CT, fluoroscopy, and digital radiography in various clinical settings. 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.

The See factor CT3 offers high-resolution imaging and multi-modality capabilities, allowing for CT, fluoroscopy, and digital radiography in various clinical settings. Epica stated that the updated clearance reflects the system’s significant improvements since its initial release in 2019. 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.

The advanced imaging technology of the See Factor CT3 enables clinicians to perform computed tomography, fluoroscopy, and digital radiography in any suitably shielded location, thus avoiding the need to move patients. This feature is particularly beneficial for critically ill or immobile patients, ensuring they receive necessary imaging without the added risk of transportation. The system’s onboard DICOM viewer allows for immediate image review by the treating physician, streamlining the diagnostic and treatment process.

Designed for acquiring detailed head, neck, and limb images in adult patients, the See Factor CT3 can also capture images of parts of the spine, thorax, and pelvic bones. It has a particular focus on areas with high X-ray attenuation, such as bony structures. 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, making it a versatile tool for a range of medical scenarios.

see factor

See Factor CT3: User-Friendly Design and Versatility Enhance Efficiency in Clinical Environments

The See Factor CT3’s user-friendly interface and compact, versatile design make it suitable for various clinical environments, from hospitals to specialized imaging centers. The device’s ability to provide high-quality imaging in multiple formats without the need for multiple machines can significantly enhance efficiency and patient care.

Epica International’s See Factor CT3 system represents a significant advancement in medical imaging technology. The updated 510(k) clearance from the FDA not only validates the improvements made to the system but also opens the door for its broader use in clinical settings. This device’s ability to provide detailed, high-resolution images quickly and efficiently can greatly benefit patient outcomes, particularly in critical care situations where timely diagnosis and treatment are crucial.

The See Factor CT3’s advanced features, such as the indexing gantry and onboard DICOM viewer, set it apart from other imaging systems. By integrating CT, fluoroscopy, and digital radiography capabilities into a single, mobile unit, Epica has created a highly versatile tool that meets the diverse needs of modern medical practice. This versatility, combined with the system’s ease of use and high-resolution imaging capabilities, makes it an invaluable addition to any clinical setting.

Furthermore, the system’s design and functionality align with current trends in medical technology, emphasizing the importance of mobility, multi-modality, and user-friendly interfaces. As healthcare continues to evolve, devices like the See Factor CT3 will play a critical role in enhancing diagnostic capabilities and improving patient care.

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In conclusion, the FDA’s updated 510(k) clearance for the See Factor CT3 system marks a significant milestone for Epica International and the field of medical imaging. This device’s advanced features and versatile applications highlight its potential to transform clinical practices, offering improved diagnostic accuracy and efficiency. As the See Factor CT3 becomes more widely adopted, it is poised to make a substantial impact on patient care, particularly in settings where traditional, fixed imaging systems are impractical. Epica International’s commitment to innovation and excellence in medical imaging is clearly demonstrated through the development and enhancement of the See Factor CT3 system.


Resource: Medical Device Network, July 01, 2024

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