K233583 - FCT iSTREAM Phase 1
(FDA 510(k) Clearance)

K233583 is an FDA 510(k) clearance for the FCT iSTREAM Phase 1, a System, X-ray, Tomography, Computed (Class II — Special Controls, product code JAK), submitted by Fujifilm Healthcare Americas Corporation (Lexington, US). The FDA issued a Cleared decision on April 26, 2024, 171 days after receiving the submission on November 7, 2023. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.