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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 / October 2026 / K262902

510(k) cleared

ECHELON Synergy

Fujifilm Corporation · Oct 9, 2026 · K262902

FDA cleared the ECHELON Synergy from Fujifilm Corporation on Oct 9, 2026 under K262902, 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 Aug 18, 2026. The decision came 52 days later, inside the 90 FDA-day goal for a 510(k).

Fujifilm Corporation has 8 other decisions in the tracker over the last 12 months: K261229 (SCENARIA View Phase 6.0), K261283 (APERTO Lucent MRI System), K253836 (FCT iStream Phase 2), K261170 (BA-004CC).

Questions & Answers

What did FDA clear under K262902?

K262902 is the FDA 510(k) for ECHELON Synergy, submitted by Fujifilm Corporation. FDA's decision date was Oct 9, 2026, under product code LNH (System, Nuclear Magnetic Resonance Imaging).

Who makes the ECHELON Synergy?

Fujifilm Corporation, based in Minato-Ku, is the applicant of record for K262902.

How long did the K262902 review take?

FDA received the submission on Aug 18, 2026 and issued its decision on Oct 9, 2026, 52 days later.

← All decisions in October 2026