FDA 510(k)

uCT 780 with uWS-CT-Dual Energy Analysis

K-번호: K253173 · 2026-01-20

신청자Shanghai United Imaging Healthcare Co., Ltd.

결정일2026-01-20

제품 코드JAK

자문 위원회RA

결정Substantially Equivalent

기기 요약

uCT 780 with uWS-CT-Dual Energy Analysis is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai United Imaging Healthcare Co., Ltd.. It received FDA 510(k) clearance on 2026-01-20 under 510(k) number K253173. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the uCT 780 with uWS-CT-Dual Energy Analysis?

uCT 780 with uWS-CT-Dual Energy Analysis is a medical device that received FDA 510(k) clearance on 2026-01-20. The listed applicant is Shanghai United Imaging Healthcare Co., Ltd.. The 510(k) number is K253173.

When did uCT 780 with uWS-CT-Dual Energy Analysis receive FDA 510(k) clearance?

uCT 780 with uWS-CT-Dual Energy Analysis received FDA 510(k) clearance on 2026-01-20, under 510(k) number K253173.

Who is the listed applicant for uCT 780 with uWS-CT-Dual Energy Analysis?

The FDA 510(k) record lists Shanghai United Imaging Healthcare Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for uCT 780 with uWS-CT-Dual Energy Analysis?

The FDA product code for uCT 780 with uWS-CT-Dual Energy Analysis is JAK.

Shanghai United Imaging Healthcare Co., Ltd.를 신청인으로 등재한 기타 기록

K253726uAngio AVIVA CX K261427uMI Panvivo (uMI Panvivo M)K260113uMR Astra K253077uOmnispace.MR K260524uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES)K253564uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES)

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