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StimCardio raises $30M to run a wrist-worn nerve stimulator alongside AF ablation FDA early alert covers every Medline brand bed after two deaths CereVasc wins an IDE to test its endovascular CSF shunt in early Alzheimer's Boston Scientific puts the August cyberattack at $150M of lost third quarter sales Boston Scientific pushes its $14.5B Penumbra close into early 2027 GT Metabolic raises a Series C from J.P. Morgan for magnetic anastomosis Ottobock leads a $10.5M Series A in prosthetic control startup Blue Arbor Abbott wins the first US approval for a transcatheter paravalvular leak device Pharaoh Neuro takes a Breakthrough designation for filtering blood out of spinal fluid StimCardio raises $30M to run a wrist-worn nerve stimulator alongside AF ablation FDA early alert covers every Medline brand bed after two deaths CereVasc wins an IDE to test its endovascular CSF shunt in early Alzheimer's Boston Scientific puts the August cyberattack at $150M of lost third quarter sales Boston Scientific pushes its $14.5B Penumbra close into early 2027 GT Metabolic raises a Series C from J.P. Morgan for magnetic anastomosis Ottobock leads a $10.5M Series A in prosthetic control startup Blue Arbor Abbott wins the first US approval for a transcatheter paravalvular leak device Pharaoh Neuro takes a Breakthrough designation for filtering blood out of spinal fluid

The Tracker / September 2026 / K253836

510(k) cleared

FCT iStream Phase 2

Fujifilm Corporation · Sep 4, 2026 · K253836

FDA cleared the FCT iStream Phase 2 from Fujifilm Corporation on Sep 4, 2026 under K253836, 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 Dec 1, 2025. The decision came 277 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: K262902 (ECHELON Synergy), K261229 (SCENARIA View Phase 6.0), K261283 (APERTO Lucent MRI System), K261170 (BA-004CC).

Questions & Answers

What did FDA clear under K253836?

K253836 is the FDA 510(k) for FCT iStream Phase 2, submitted by Fujifilm Corporation. FDA's decision date was Sep 4, 2026, under product code JAK (System, X-Ray, Tomography, Computed).

Who makes the FCT iStream Phase 2?

Fujifilm Corporation, based in Minato-Ku, is the applicant of record for K253836.

How long did the K253836 review take?

FDA received the submission on Dec 1, 2025 and issued its decision on Sep 4, 2026, 277 days later.

← All decisions in September 2026