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FDA 510(k)

uCT 520, uCT 528

K-Number: K183143 · 2019-01-03

ApplicantShangai United Imaging Healthcare Co., Ltd.
Decision Date2019-01-03
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

uCT 520, uCT 528 is a medical device manufactured by Shangai United Imaging Healthcare Co., Ltd.. It received FDA 510(k) clearance on 2019-01-03 under approval number K183143. 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 520, uCT 528?

uCT 520, uCT 528 is a medical device that received FDA 510(k) clearance on 2019-01-03. It is manufactured by Shangai United Imaging Healthcare Co., Ltd.. The 510(k) number is K183143.

When was uCT 520, uCT 528 approved by the FDA?

uCT 520, uCT 528 received FDA 510(k) clearance on 2019-01-03, under approval number K183143.

What company makes uCT 520, uCT 528?

uCT 520, uCT 528 is manufactured by Shangai United Imaging Healthcare Co., Ltd..

What is the FDA product code for uCT 520, uCT 528?

The FDA product code for uCT 520, uCT 528 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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