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FDA 510(k)

uCT 760 with uWS-CT-Dual Energy Analysis, uCT 780 with uWS-CT-Dual Energy Analysis

K-Number: K230162 · 2023-08-01

ApplicantShanghai United Imaging Healthcare Co., Ltd.
Decision Date2023-08-01
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

uCT 760 with uWS-CT-Dual Energy Analysis, uCT 780 with uWS-CT-Dual Energy Analysis is a medical device manufactured by Shanghai United Imaging Healthcare Co., Ltd.. It received FDA 510(k) clearance on 2023-08-01 under approval number K230162. 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 760 with uWS-CT-Dual Energy Analysis, uCT 780 with uWS-CT-Dual Energy Analysis?

uCT 760 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 2023-08-01. It is manufactured by Shanghai United Imaging Healthcare Co., Ltd.. The 510(k) number is K230162.

When was uCT 760 with uWS-CT-Dual Energy Analysis, uCT 780 with uWS-CT-Dual Energy Analysis approved by the FDA?

uCT 760 with uWS-CT-Dual Energy Analysis, uCT 780 with uWS-CT-Dual Energy Analysis received FDA 510(k) clearance on 2023-08-01, under approval number K230162.

What company makes uCT 760 with uWS-CT-Dual Energy Analysis, uCT 780 with uWS-CT-Dual Energy Analysis?

uCT 760 with uWS-CT-Dual Energy Analysis, uCT 780 with uWS-CT-Dual Energy Analysis is manufactured by Shanghai United Imaging Healthcare Co., Ltd..

What is the FDA product code for uCT 760 with uWS-CT-Dual Energy Analysis, uCT 780 with uWS-CT-Dual Energy Analysis?

The FDA product code for uCT 760 with uWS-CT-Dual Energy Analysis, uCT 780 with uWS-CT-Dual Energy Analysis is JAK.

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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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