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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 / K254189

510(k) cleared

Synapse 3D Base Tools (V7.2)

Fujifilm Corporation · Apr 30, 2026 · K254189

FDA cleared the Synapse 3D Base Tools (V7.2) from Fujifilm Corporation on Apr 30, 2026 under K254189, a traditional 510(k). The device falls under product code QIH, Automated Radiological Image Processing Software, regulated at 21 CFR 892.2050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Dec 23, 2025. The decision came 128 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 K254189?

K254189 is the FDA 510(k) for Synapse 3D Base Tools (V7.2), submitted by Fujifilm Corporation. FDA's decision date was Apr 30, 2026, under product code QIH (Automated Radiological Image Processing Software).

Who makes the Synapse 3D Base Tools (V7.2)?

Fujifilm Corporation, based in Minato-Ku, Tokyo, is the applicant of record for K254189.

How long did the K254189 review take?

FDA received the submission on Dec 23, 2025 and issued its decision on Apr 30, 2026, 128 days later.

← All decisions in April 2026