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Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets

The Tracker / April 2026 / K253862

510(k) cleared

APERTO Lucent MRI System

Fujifilm Corporation · Apr 6, 2026 · K253862

FDA cleared the APERTO Lucent MRI System from Fujifilm Corporation on Apr 6, 2026 under K253862, 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 Dec 3, 2025. The decision came 124 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), K253836 (FCT iStream Phase 2).

Questions & Answers

What did FDA clear under K253862?

K253862 is the FDA 510(k) for APERTO Lucent MRI System, submitted by Fujifilm Corporation. FDA's decision date was Apr 6, 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 K253862.

How long did the K253862 review take?

FDA received the submission on Dec 3, 2025 and issued its decision on Apr 6, 2026, 124 days later.

← All decisions in April 2026