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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 / K262301

510(k) cleared

Rapid ICH (v4.0)

Ischemaview, Inc. · Oct 9, 2026 · K262301

FDA cleared the Rapid ICH (v4.0) from Ischemaview, Inc. on Oct 9, 2026 under K262301, 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 Jul 7, 2026. The decision came 94 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Ischemaview, Inc. has 2 other decisions in the tracker over the last 12 months: K261368 (Rapid Platform (R6.7)), K261085 (Rapid Vessel Occlusion (Rapid VO)).

Questions & Answers

What did FDA clear under K262301?

K262301 is the FDA 510(k) for Rapid ICH (v4.0), submitted by Ischemaview, Inc.. FDA's decision date was Oct 9, 2026, under product code QAS (Radiological Computer-Assisted Triage And Notification Software).

Who makes the Rapid ICH (v4.0)?

Ischemaview, Inc., based in Golden, CO, is the applicant of record for K262301.

How long did the K262301 review take?

FDA received the submission on Jul 7, 2026 and issued its decision on Oct 9, 2026, 94 days later.

← All decisions in October 2026

Sources