# K233230: See Factor CT3™

- Pathway: 510(k) (Traditional)
- Applicant: Epica International, Inc.
- Decided: Jun 21, 2024 after 267 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K801623 (1980). 46 ancestors in all.
No later device cites it as a predicate yet.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181407: Artis zee/zeego & Artis Q/Q.zen, Siemens Medical Solution USA, Inc. (2018) Summary page 4.

## Indications for 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. The device is to be operated by licensed and credentialed medical professionals such as physicians, and radiology technicians.

Source page: https://510kreport.com/device/K233230
Methodology: https://510kreport.com/methodology