Cleared Traditional

K253836 - FCT iStream Phase 2

K253836 is an FDA 510(k) clearance for FCT iStream Phase 2, manufactured by Fujifilm Corporation. The device is a Class 2 Radiology device with product code JAK cleared through the Traditional 510(k) pathway after a 277-day FDA review.

K253836 · Fujifilm Corporation · Radiology device
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Sep 2026
Decision
277d
Days
Class 2
Risk

K253836 is an FDA 510(k) clearance for the FCT iStream Phase 2. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Fujifilm Corporation (Minato-Ku, JP). The FDA issued a Cleared decision on September 4, 2026 after a review of 277 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1750 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Fujifilm Corporation devices

FDA 510(k) Submission Details - K253836

510(k) Number K253836 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 2025
Decision Date September 04, 2026
Days to Decision 277 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
170d slower than avg
Panel avg: 107d · This submission: 277d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JAK Device Classification - Class 2, Special Controls

Product Code JAK System, X-ray, Tomography, Computed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1750
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Consultant

FUJIFILM Healthcare Americas Corporation
Chaitrali Kulkarni

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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