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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 / K260092

510(k) cleared

Vista AI Scan

Vista AI, Inc. · Oct 7, 2026 · K260092

FDA cleared the Vista AI Scan from Vista AI, Inc. on Oct 7, 2026 under K260092, 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 Jan 12, 2026. The decision came 268 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Vista AI, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260092?

K260092 is the FDA 510(k) for Vista AI Scan, submitted by Vista AI, Inc.. FDA's decision date was Oct 7, 2026, under product code LNH (System, Nuclear Magnetic Resonance Imaging).

Who makes the Vista AI Scan?

Vista AI, Inc., based in Palo Alto, CA, is the applicant of record for K260092.

How long did the K260092 review take?

FDA received the submission on Jan 12, 2026 and issued its decision on Oct 7, 2026, 268 days later.

← All decisions in October 2026