FCT iStream Phase 2— 510(k) K253836
Substantially EquivalentFujifilm Corporation
FDA 510(k) clearance K253836 for FCT iStream Phase 2, Substantially Equivalent on 2026-09-04. Applicant: Fujifilm Corporation. Device class: 2.
Summary
Fujifilm's FCT iStream Phase 2 is filed under JAK, computed tomography x-ray systems. The record doesn't say what "Phase 2" refers to.
Class II, 21 CFR 892.1750. Radiology is both the classification panel and the review panel, and the submission was a Traditional 510(k).
Fujifilm filed from Minato-Ku, Japan. Review took 277 calendar days (December 1, 2025 to September 4, 2026).
Clearance details
- Applicant
- Fujifilm Corporation
- Product code
- Product code JAK
- Device class
- Class 2
- Regulation
- 21 CFR 892.1750
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Minato-Ku, JP
Recent devices under product code JAK
view allMore clearances from Fujifilm Corporation
view allAdverse events under product code JAK
product code JAK- Death
- 27
- Injury
- 571
- Malfunction
- 779
- Total
- 1,377
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.