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The Tracker / September 2026 / K261283

510(k) cleared

APERTO Lucent MRI System

Fujifilm Corporation · Sep 16, 2026 · K261283

FDA cleared the APERTO Lucent MRI System from Fujifilm Corporation on Sep 16, 2026 under K261283, a traditional 510(k). The device falls under product code LNH, System, Nuclear Magnetic Resonance Imaging, regulated at 21 CFR 892.1000 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Apr 17, 2026. The decision came 152 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: K261229 (SCENARIA View Phase 6.0), K253836 (FCT iStream Phase 2), K261170 (BA-004CC), K260567 (EW10-EC02 Endoscopy Support Program).

Questions & Answers

What did FDA clear under K261283?

K261283 is the FDA 510(k) for APERTO Lucent MRI System, submitted by Fujifilm Corporation. FDA's decision date was Sep 16, 2026, under product code LNH (System, Nuclear Magnetic Resonance Imaging).

Who makes the APERTO Lucent MRI System?

Fujifilm Corporation, based in Minato-Ku, is the applicant of record for K261283.

How long did the K261283 review take?

FDA received the submission on Apr 17, 2026 and issued its decision on Sep 16, 2026, 152 days later.

← All decisions in September 2026