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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 the device name listed in this FDA 510(k) record. The listed applicant is Shangai United Imaging Healthcare Co., Ltd.. It received FDA 510(k) clearance on 2019-01-03 under 510(k) 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. The listed applicant is Shangai United Imaging Healthcare Co., Ltd.. The 510(k) number is K183143.

When did uCT 520, uCT 528 receive FDA 510(k) clearance?

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

Who is the listed applicant for uCT 520, uCT 528?

The FDA 510(k) record lists Shangai 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 520, uCT 528?

The FDA product code for uCT 520, uCT 528 is JAK.

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Official Source

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

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