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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 / September 2026 / K261313

510(k) cleared

Vivid Explorer/Vivid Advanced/Vivid Focus

GE Medical Systems Ultrasound and Primary Care Diagnostics · Sep 2, 2026 · K261313

FDA cleared the Vivid Explorer/Vivid Advanced/Vivid Focus from GE Medical Systems Ultrasound and Primary Care Diagnostics on Sep 2, 2026 under K261313, a traditional 510(k). The device falls under product code IYN, System, Imaging, Pulsed Doppler, Ultrasonic, regulated at 21 CFR 892.1550 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Apr 21, 2026. The decision came 134 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

GE Medical Systems Ultrasound and Primary Care Diagnostics has 8 other decisions in the tracker over the last 12 months: K261933 (Voluson Expert 18; Voluson Expert 20; Voluson Expert 22), K261623 (EchoPAC Software Only / EchoPAC Plug-in (v211)), K261668 (Venue Go), K261835 (LOGIQ Focus).

Questions & Answers

What did FDA clear under K261313?

K261313 is the FDA 510(k) for Vivid Explorer/Vivid Advanced/Vivid Focus, submitted by GE Medical Systems Ultrasound and Primary Care Diagnostics. FDA's decision date was Sep 2, 2026, under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic).

Who makes the Vivid Explorer/Vivid Advanced/Vivid Focus?

GE Medical Systems Ultrasound and Primary Care Diagnostics, based in Waukesha, WI, is the applicant of record for K261313.

How long did the K261313 review take?

FDA received the submission on Apr 21, 2026 and issued its decision on Sep 2, 2026, 134 days later.

← All decisions in September 2026