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FDA 510(k)

uCT 530, uCT 550

K-Number: K181414 · 2018-08-14

ApplicantShanghai United Imaging Healthcare Co., Ltd.
Decision Date2018-08-14
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

uCT 530, uCT 550 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 2018-08-14 under 510(k) number K181414. 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 530, uCT 550?

uCT 530, uCT 550 is a medical device that received FDA 510(k) clearance on 2018-08-14. The listed applicant is Shanghai United Imaging Healthcare Co., Ltd.. The 510(k) number is K181414.

When did uCT 530, uCT 550 receive FDA 510(k) clearance?

uCT 530, uCT 550 received FDA 510(k) clearance on 2018-08-14, under 510(k) number K181414.

Who is the listed applicant for uCT 530, uCT 550?

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 530, uCT 550?

The FDA product code for uCT 530, uCT 550 is JAK.

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

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.

K261427uMI Panvivo (uMI Panvivo M)K260113uMR AstraK253077uOmnispace.MRK260524uMI 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)K253173uCT 780 with uWS-CT-Dual Energy Analysis

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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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