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StimCardio raises $30M to run a wrist-worn nerve stimulator alongside AF ablation FDA early alert covers every Medline brand bed after two deaths CereVasc wins an IDE to test its endovascular CSF shunt in early Alzheimer's Boston Scientific puts the August cyberattack at $150M of lost third quarter sales Boston Scientific pushes its $14.5B Penumbra close into early 2027 GT Metabolic raises a Series C from J.P. Morgan for magnetic anastomosis Ottobock leads a $10.5M Series A in prosthetic control startup Blue Arbor Abbott wins the first US approval for a transcatheter paravalvular leak device Pharaoh Neuro takes a Breakthrough designation for filtering blood out of spinal fluid StimCardio raises $30M to run a wrist-worn nerve stimulator alongside AF ablation FDA early alert covers every Medline brand bed after two deaths CereVasc wins an IDE to test its endovascular CSF shunt in early Alzheimer's Boston Scientific puts the August cyberattack at $150M of lost third quarter sales Boston Scientific pushes its $14.5B Penumbra close into early 2027 GT Metabolic raises a Series C from J.P. Morgan for magnetic anastomosis Ottobock leads a $10.5M Series A in prosthetic control startup Blue Arbor Abbott wins the first US approval for a transcatheter paravalvular leak device Pharaoh Neuro takes a Breakthrough designation for filtering blood out of spinal fluid

The Tracker / August 2026 / K260488

510(k) cleared

MULTIX Impact; MULTIX Impact C

Siemens Medical Solutions USA, Inc. · Aug 31, 2026 · K260488

FDA cleared the MULTIX Impact; MULTIX Impact C from Siemens Medical Solutions USA, Inc. on Aug 31, 2026 under K260488, a traditional 510(k). The device falls under product code KPR, System, X-Ray, Stationary, regulated at 21 CFR 892.1680 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Feb 13, 2026. The decision came 199 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: K260055 (syngo.CT Brain Quantification), K261696 (ACUNAV Luxera 4D ICE Catheter), K253786 (syngo.CT Coronary Cockpit), K253678 (MAMMOMAT B.brilliant (11372950)).

Questions & Answers

What did FDA clear under K260488?

K260488 is the FDA 510(k) for MULTIX Impact; MULTIX Impact C, submitted by Siemens Medical Solutions USA, Inc.. FDA's decision date was Aug 31, 2026, under product code KPR (System, X-Ray, Stationary).

Who makes the MULTIX Impact; MULTIX Impact C?

Siemens Medical Solutions USA, Inc., based in Malvern, PA, is the applicant of record for K260488.

How long did the K260488 review take?

FDA received the submission on Feb 13, 2026 and issued its decision on Aug 31, 2026, 199 days later.

← All decisions in August 2026