# K253836: FCT iStream Phase 2

- Pathway: 510(k) (Traditional)
- Applicant: Fujifilm Corporation
- Decided: Sep 4, 2026 after 277 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K031469 (2003). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K250370: SCENARIA View Phase 5.0, Fujifilm Corporation (2025) Summary page 5.

## Indications for use
The FCT iStream system is indicated to acquire axial volumes of the whole body including the head. Images can be acquired in axial, helical, or dynamic modes. The FCT iStream system can also be used for interventional needle guidance. Volume datasets acquired by an FCT iStream system can be post-processed in the FCT iStream system to provide additional information. Post-processing capabilities of the FCT iStream software include multi-planar reconstruction (MPR), and volume rendering. Volume datasets acquired by an FCT iStream system can be transferred to external devices via a DICOM standard interface. The Low Dose CT Lung Cancer Screening Option for the FCT iStream system is indicated for using low dose CT for lung cancer screening. The screening must be conducted with the established program criteria and protocols that have been approved and published by a governmental body, a professional medical society, and/or FUJIFILM Corporation. AI/ML algorithms are used for Intelli IPV, AutoPose and AutoPositioning. Intelli IPV is an iterative image reconstruction function incorporating machine learning-based AI technology. AutoPose is developed using deep learning as AI technology to detect landmarks or regions from a scanogram image. When using AutoPose, be sure to visually check the scan range and adjust it if necessary. AutoPositioning is developed using deep learning as AI technology to detect the patient’s feature points. This function assists in patient positioning operations. Therefore, after completing the positioning operation, be sure to visually check the patient's positioning and the table position by using the light localizer. AutoPose and AutoPositioning are for adult use only.

Source page: https://510kreport.com/device/K253836
Methodology: https://510kreport.com/methodology