510(k) clearance

FCT iStream Phase 2

FDA 510(k) source

510(k) number

K253836

Applicant

Fujifilm Corporation

Decision date

Sep 4, 2026

Date received

Dec 1, 2025

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

JAK

Device type

System, X-Ray, Tomography, Computed

Device class

Class II

Regulation

21 CFR 892.1750

Advisory committee

Radiology

Statement or summary

Summary

Third party

N

Location

Minato-Ku, JP