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FDA 510(k)

uMC 560i

K-Number: K183144 · 2019-12-19

ApplicantShanghai United Imaging Healthcare Co., Ltd.
Decision Date2019-12-19
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

uMC 560i 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 2019-12-19 under 510(k) number K183144. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the uMC 560i?

uMC 560i is a medical device that received FDA 510(k) clearance on 2019-12-19. The listed applicant is Shanghai United Imaging Healthcare Co., Ltd.. The 510(k) number is K183144.

When did uMC 560i receive FDA 510(k) clearance?

uMC 560i received FDA 510(k) clearance on 2019-12-19, under 510(k) number K183144.

Who is the listed applicant for uMC 560i?

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 uMC 560i?

The FDA product code for uMC 560i is OWB.

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

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Related Devices (Code: OWB)

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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