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FDA makes the Draeger VentStar Resus Neo hose removal a Class I recall Control Bionics wins a Class I CE mark for the NeuroStrip muscle sensor Medicare starts paying for Carlsmed Aprevo lumbar fusion under three new codes ABK Biomedical breaks ground on a Missouri plant for its Y90 microspheres Boston Scientific releases the last $8M from Elutia's BioEnvelope sale BlueWind gets a Category I CPT code for subfascial tibial neuromodulation Emboline runs its first US commercial Emboliner cases at Columbia SedMed raises $4M for a toilet lift that runs without power CDRH plans 11 final guidances in FY2027 and puts AI lifecycle management first FDA makes the Draeger VentStar Resus Neo hose removal a Class I recall Control Bionics wins a Class I CE mark for the NeuroStrip muscle sensor Medicare starts paying for Carlsmed Aprevo lumbar fusion under three new codes ABK Biomedical breaks ground on a Missouri plant for its Y90 microspheres Boston Scientific releases the last $8M from Elutia's BioEnvelope sale BlueWind gets a Category I CPT code for subfascial tibial neuromodulation Emboline runs its first US commercial Emboliner cases at Columbia SedMed raises $4M for a toilet lift that runs without power CDRH plans 11 final guidances in FY2027 and puts AI lifecycle management first

The Tracker / September 2026 / K261368

510(k) cleared

Rapid Platform (R6.7)

Ischemaview, Inc. · Sep 21, 2026 · K261368

FDA cleared the Rapid Platform (R6.7) from Ischemaview, Inc. on Sep 21, 2026 under K261368, a traditional 510(k). The device falls under product code QIH, Automated Radiological Image Processing Software, regulated at 21 CFR 892.2050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Apr 27, 2026. The decision came 147 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Ischemaview, Inc. has one other decision in the tracker over the last 12 months: K261085 (Rapid Vessel Occlusion (Rapid VO)).

Questions & Answers

What did FDA clear under K261368?

K261368 is the FDA 510(k) for Rapid Platform (R6.7), submitted by Ischemaview, Inc.. FDA's decision date was Sep 21, 2026, under product code QIH (Automated Radiological Image Processing Software).

Who makes the Rapid Platform (R6.7)?

Ischemaview, Inc., based in Golden, CO, is the applicant of record for K261368.

How long did the K261368 review take?

FDA received the submission on Apr 27, 2026 and issued its decision on Sep 21, 2026, 147 days later.

← All decisions in September 2026

Sources