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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 / K260055

510(k) cleared

syngo.CT Brain Quantification

Siemens Medical Solutions USA, Inc. · Sep 25, 2026 · K260055

FDA cleared the syngo.CT Brain Quantification from Siemens Medical Solutions USA, Inc. on Sep 25, 2026 under K260055, 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 Jan 8, 2026. The decision came 260 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Siemens Medical Solutions USA, Inc. has 8 other decisions in the tracker over the last 12 months: K261696 (ACUNAV Luxera 4D ICE Catheter), K260488 (MULTIX Impact; MULTIX Impact C), K253786 (syngo.CT Coronary Cockpit), K253678 (MAMMOMAT B.brilliant (11372950)).

Questions & Answers

What did FDA clear under K260055?

K260055 is the FDA 510(k) for syngo.CT Brain Quantification, submitted by Siemens Medical Solutions USA, Inc.. FDA's decision date was Sep 25, 2026, under product code QIH (Automated Radiological Image Processing Software).

Who makes the syngo.CT Brain Quantification?

Siemens Medical Solutions USA, Inc., based in Knoxville, TN, is the applicant of record for K260055.

How long did the K260055 review take?

FDA received the submission on Jan 8, 2026 and issued its decision on Sep 25, 2026, 260 days later.

← All decisions in September 2026