FDA 510(k)

EchoPAC Software Only / EchoPAC Plug-in

K-번호: K251342 · 2025-07-16

신청자GE Medical Systems Ultrasound and Primary Care Diagnostics

결정일2025-07-16

제품 코드QIH

자문 위원회RA

결정Substantially Equivalent

기기 요약

EchoPAC Software Only / EchoPAC Plug-in 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 2025-07-16 under 510(k) number K251342. 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?

EchoPAC Software Only / EchoPAC Plug-in is a medical device that received FDA 510(k) clearance on 2025-07-16. The listed applicant is GE Medical Systems Ultrasound and Primary Care Diagnostics. The 510(k) number is K251342.

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

EchoPAC Software Only / EchoPAC Plug-in received FDA 510(k) clearance on 2025-07-16, under 510(k) number K251342.

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

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?

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

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

K261623EchoPAC Software Only / EchoPAC Plug-in (v211)K261313Vivid Explorer/Vivid Advanced/Vivid Focus K261835LOGIQ Focus K260398LOGIQ e K260673LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ S20; LOGIQ S20 Pro; LOGIQ S20 Express; LOGIQ S20 Plus; LOGIQ S20 Power K253370LOGIQ Totus

65개 장치 모두 보기 →

공식 출처

FDA 데이터베이스에서 보기 →

FDA Open API에서 수집된 데이터입니다. 가장 정확하고 공인된 정보는 항상 공식 레코드를 참조하시기 바랍니다.