FDA 510(k)

EchoPAC Software Only / EchoPAC Plug-in (v211)

K-번호: K261623 · 2026-09-16

신청자GE Medical Systems Ultrasound and Primary Care Diagnostics

결정일2026-09-16

제품 코드QIH

자문 위원회RA

결정Substantially Equivalent

기기 요약

EchoPAC Software Only / EchoPAC Plug-in (v211) is the device name listed in this FDA 510(k) record. The listed applicant is GE Medical Systems Ultrasound and Primary Care Diagnostics. It received FDA 510(k) clearance on 2026-09-16 under 510(k) number K261623. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the EchoPAC Software Only / EchoPAC Plug-in (v211)?

EchoPAC Software Only / EchoPAC Plug-in (v211) is a medical device that received FDA 510(k) clearance on 2026-09-16. The listed applicant is GE Medical Systems Ultrasound and Primary Care Diagnostics. The 510(k) number is K261623.

When did EchoPAC Software Only / EchoPAC Plug-in (v211) receive FDA 510(k) clearance?

EchoPAC Software Only / EchoPAC Plug-in (v211) received FDA 510(k) clearance on 2026-09-16, under 510(k) number K261623.

Who is the listed applicant for EchoPAC Software Only / EchoPAC Plug-in (v211)?

The FDA 510(k) record lists GE Medical Systems Ultrasound and Primary Care Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EchoPAC Software Only / EchoPAC Plug-in (v211)?

The FDA product code for EchoPAC Software Only / EchoPAC Plug-in (v211) is QIH.

GE Medical Systems Ultrasound and Primary Care Diagnostics를 신청인으로 등재한 기타 기록

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