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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 / K261874

510(k) cleared

Syneris PACS v.1.0.1.0

Syneris · Sep 23, 2026 · K261874

FDA cleared the Syneris PACS v.1.0.1.0 from Syneris on Sep 23, 2026 under K261874, a traditional 510(k). The device falls under product code LLZ, System, Image Processing, Radiological, regulated at 21 CFR 892.2050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Jun 5, 2026. The decision came 110 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 Syneris in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261874?

K261874 is the FDA 510(k) for Syneris PACS v.1.0.1.0, submitted by Syneris. FDA's decision date was Sep 23, 2026, under product code LLZ (System, Image Processing, Radiological).

Who makes the Syneris PACS v.1.0.1.0?

Syneris, based in Concord, is the applicant of record for K261874.

How long did the K261874 review take?

FDA received the submission on Jun 5, 2026 and issued its decision on Sep 23, 2026, 110 days later.

← All decisions in September 2026