Cleared Traditional

K233583 - FCT iSTREAM Phase 1

K233583 is an FDA 510(k) clearance for FCT iSTREAM Phase 1, manufactured by Fujifilm Healthcare Americas Corporation. The device is a Class 2 Radiology device with product code JAK cleared through the Traditional 510(k) pathway after a 171-day FDA review.

K233583 · Fujifilm Healthcare Americas Corporation · Radiology device
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Apr 2024
Decision
171d
Days
Class 2
Risk

K233583 is an FDA 510(k) clearance for the FCT iSTREAM Phase 1. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Fujifilm Healthcare Americas Corporation (Lexington, US). The FDA issued a Cleared decision on April 26, 2024 after a review of 171 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 Healthcare Americas Corporation devices

FDA 510(k) Submission Details - K233583

510(k) Number K233583 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 2023
Decision Date April 26, 2024
Days to Decision 171 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
64d slower than avg
Panel avg: 107d · This submission: 171d
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 Peers - JAK System, X-ray, Tomography, Computed

All 635
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