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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 / September 2026 / K262015

510(k) cleared

Elucid FFR-IQ (B.1)

Elucid Bioimaging, Inc. · Sep 29, 2026 · K262015 · In the directory

FDA cleared the Elucid FFR-IQ (B.1) from Elucid Bioimaging, Inc. on Sep 29, 2026 under K262015, a traditional 510(k). The device falls under product code PJA, Coronary Vascular Physiologic Simulation Software, regulated at 21 CFR 870.1415 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Jun 15, 2026. The decision came 106 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Elucid Bioimaging, Inc. has one other decision in the tracker over the last 12 months: K261855 (Elucid PlaqueIQ).

Questions & Answers

What did FDA clear under K262015?

K262015 is the FDA 510(k) for Elucid FFR-IQ (B.1), submitted by Elucid Bioimaging, Inc.. FDA's decision date was Sep 29, 2026, under product code PJA (Coronary Vascular Physiologic Simulation Software).

Who makes the Elucid FFR-IQ (B.1)?

Elucid Bioimaging, Inc., based in Boston, MA, is the applicant of record for K262015. The company is listed in the MedDevice Startups directory.

How long did the K262015 review take?

FDA received the submission on Jun 15, 2026 and issued its decision on Sep 29, 2026, 106 days later.

← All decisions in September 2026

Sources

In the startup directory

Elucid

Imaging & Radiology · Boston, MA