Cleared Traditional

SCENARIA View Phase 5.0

K250370 · Fujifilm Corporation · Radiology
May 2025
Decision
99d
Days
Class 2
Risk

About This 510(k) Submission

K250370 is an FDA 510(k) clearance for the SCENARIA View Phase 5.0, a System, X-ray, Tomography, Computed (Class II — Special Controls, product code JAK), submitted by Fujifilm Corporation (Minato-Ku, JP). The FDA issued a Cleared decision on May 20, 2025, 99 days after receiving the submission on February 10, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number K250370 FDA.gov
FDA Decision Cleared SESE
Date Received February 10, 2025
Decision Date May 20, 2025
Days to Decision 99 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code JAK — System, X-ray, Tomography, Computed
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1750

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