Search Results
Found 1 results
510(k) Data Aggregation
K Number
K233230Device Name
See Factor CT3
Manufacturer
Date Cleared
2024-06-21
(267 days)
Regulation Number
892.1650Why did this record match?
Applicant Name (Manufacturer) :
Epica International, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The See Factor CT3™ is a flat panel cone beam computed tomography X-ray imaging system that is indicated for acquiring images of the head, neck, and limbs in all adult patients. It can also acquire portions of the thorax, spine, and pelvic bones with high x-ray attenuation such as bony structures in supine body parts no wider than 60cm. The device has a 62.5cm gantry bore with a 30cm field of view that can provide 2D and 3D images for all of the stated anatomical areas for both intra-operative and clinical use. The device is also capable of acquiring digital radiography and fluoroscopy images of the anatomical areas identified above.
Device Description
The See Factor CT3™ consists of a Diagnostic CBCT (Cone Beam Computed Tomography) device that integrates High-Definition Computed Tomography (HDCT) for obtaining High Resolution 3D Volume with 2D High Resolution Scouting, through Dynamic Scouting and Single Pulse Modality. Flat panel detector technology allows for multimodality utilization for computed tomography, digital radiography, and fluoroscopy. The gantry of the device is mounted to a battery powered mobile platform that allows use in various clinical settings such as an imaging center, a hospital, or an operating room where adequate radiation shielding is installed. Stray radiation mapping demonstrates no significant difference from the predicate See Factor CT3. The energy source and methodology for obtaining diagnostic CT images utilized by the See Factor CT3™ remains the same as its predicate device. No part of the See Factor CT3™ is intended to come into contact with patients during typical scans that take less than 20 minutes.
Ask a Question
Ask a specific question about this device
Page 1 of 1