FDA 510(k)

Vivid Explorer/Vivid Advanced/Vivid Focus

K-번호: K261313 · 2026-09-02

신청자GE Medical Systems Ultrasound and Primary Care Diagnostics

결정일2026-09-02

제품 코드IYN

자문 위원회RA

결정Substantially Equivalent

기기 요약

Vivid Explorer/Vivid Advanced/Vivid Focus 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 2026-09-02 under 510(k) number K261313. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Vivid Explorer/Vivid Advanced/Vivid Focus?

Vivid Explorer/Vivid Advanced/Vivid Focus is a medical device that received FDA 510(k) clearance on 2026-09-02. The listed applicant is GE Medical Systems Ultrasound and Primary Care Diagnostics. The 510(k) number is K261313.

When did Vivid Explorer/Vivid Advanced/Vivid Focus receive FDA 510(k) clearance?

Vivid Explorer/Vivid Advanced/Vivid Focus received FDA 510(k) clearance on 2026-09-02, under 510(k) number K261313.

Who is the listed applicant for Vivid Explorer/Vivid Advanced/Vivid Focus?

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 Vivid Explorer/Vivid Advanced/Vivid Focus?

The FDA product code for Vivid Explorer/Vivid Advanced/Vivid Focus is IYN.

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

K261623EchoPAC Software Only / EchoPAC Plug-in (v211)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 K253366LOGIQ Fortis

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