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The Tracker / September 2026 / K261623

510(k) cleared

EchoPAC Software Only / EchoPAC Plug-in (v211)

GE Medical Systems Ultrasound and Primary Care Diagnostics · Sep 16, 2026 · K261623

FDA cleared the EchoPAC Software Only / EchoPAC Plug-in (v211) from GE Medical Systems Ultrasound and Primary Care Diagnostics on Sep 16, 2026 under K261623, 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 May 15, 2026. The decision came 124 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: K261313 (Vivid Explorer/Vivid Advanced/Vivid Focus), K261668 (Venue Go), K261835 (LOGIQ Focus), K260398 (LOGIQ e).

Questions & Answers

What did FDA clear under K261623?

K261623 is the FDA 510(k) for EchoPAC Software Only / EchoPAC Plug-in (v211), submitted by GE Medical Systems Ultrasound and Primary Care Diagnostics. FDA's decision date was Sep 16, 2026, under product code QIH (Automated Radiological Image Processing Software).

Who makes the EchoPAC Software Only / EchoPAC Plug-in (v211)?

GE Medical Systems Ultrasound and Primary Care Diagnostics, based in Waukesha, WI, is the applicant of record for K261623.

How long did the K261623 review take?

FDA received the submission on May 15, 2026 and issued its decision on Sep 16, 2026, 124 days later.

← All decisions in September 2026