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FDA 510(k)

uCT 780 with uWS-CT-Dual Energy Analysis

K-Number: K253173 · 2026-01-20

ApplicantShanghai United Imaging Healthcare Co., Ltd.
Decision Date2026-01-20
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Other records listing Shanghai United Imaging Healthcare Co., Ltd. as applicant

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Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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