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The Tracker / September 2026 / K261229

510(k) cleared

SCENARIA View Phase 6.0

Fujifilm Corporation · Sep 18, 2026 · K261229

FDA cleared the SCENARIA View Phase 6.0 from Fujifilm Corporation on Sep 18, 2026 under K261229, a traditional 510(k). The device falls under product code JAK, System, X-Ray, Tomography, Computed, regulated at 21 CFR 892.1750 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Apr 15, 2026. The decision came 156 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Fujifilm Corporation has 8 other decisions in the tracker over the last 12 months: K261283 (APERTO Lucent MRI System), K253836 (FCT iStream Phase 2), K261170 (BA-004CC), K260567 (EW10-EC02 Endoscopy Support Program).

Questions & Answers

What did FDA clear under K261229?

K261229 is the FDA 510(k) for SCENARIA View Phase 6.0, submitted by Fujifilm Corporation. FDA's decision date was Sep 18, 2026, under product code JAK (System, X-Ray, Tomography, Computed).

Who makes the SCENARIA View Phase 6.0?

Fujifilm Corporation, based in Minato-Ku, is the applicant of record for K261229.

How long did the K261229 review take?

FDA received the submission on Apr 15, 2026 and issued its decision on Sep 18, 2026, 156 days later.

← All decisions in September 2026