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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 / July 2026 / K261085

510(k) cleared

Rapid Vessel Occlusion (Rapid VO)

iSchemaview · Jul 13, 2026 · K261085

FDA cleared the Rapid Vessel Occlusion (Rapid VO) from iSchemaview on Jul 13, 2026 under K261085, a traditional 510(k). The device falls under product code QAS, Radiological Computer-Assisted Triage And Notification Software, regulated at 21 CFR 892.2080 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Apr 1, 2026. The decision came 103 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

iSchemaview has 2 other decisions in the tracker over the last 12 months: K262301 (Rapid ICH (v4.0)), K261368 (Rapid Platform (R6.7)).

Questions & Answers

What did FDA clear under K261085?

K261085 is the FDA 510(k) for Rapid Vessel Occlusion (Rapid VO), submitted by iSchemaview. FDA's decision date was Jul 13, 2026, under product code QAS (Radiological Computer-Assisted Triage And Notification Software).

Who makes the Rapid Vessel Occlusion (Rapid VO)?

iSchemaview, based in Golden, CO, is the applicant of record for K261085.

How long did the K261085 review take?

FDA received the submission on Apr 1, 2026 and issued its decision on Jul 13, 2026, 103 days later.

← All decisions in July 2026

Sources