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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 / May 2026 / K254075

510(k) cleared

Synapse Lung Nodule AI

Fujifilm Corporation · May 27, 2026 · K254075

FDA cleared the Synapse Lung Nodule AI from Fujifilm Corporation on May 27, 2026 under K254075, a traditional 510(k). The device falls under product code OEB, Lung Computed Tomography System, Computer-Aided Detection, regulated at 21 CFR 892.2050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Dec 18, 2025. The decision came 160 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 K254075?

K254075 is the FDA 510(k) for Synapse Lung Nodule AI, submitted by Fujifilm Corporation. FDA's decision date was May 27, 2026, under product code OEB (Lung Computed Tomography System, Computer-Aided Detection).

Who makes the Synapse Lung Nodule AI?

Fujifilm Corporation, based in Minato-Ku, Tokyo, is the applicant of record for K254075.

How long did the K254075 review take?

FDA received the submission on Dec 18, 2025 and issued its decision on May 27, 2026, 160 days later.

← All decisions in May 2026