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FDA 510(k)

uMI Panorama

K-Number: K223325 · 2023-03-10

Decision Date2023-03-10
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

uMI Panorama is a medical device manufactured by Shanghai United Imaging Healthcare Co., Ltd.. It received FDA 510(k) clearance on 2023-03-10 under approval number K223325. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the uMI Panorama?

uMI Panorama is a medical device that received FDA 510(k) clearance on 2023-03-10. It is manufactured by Shanghai United Imaging Healthcare Co., Ltd.. The 510(k) number is K223325.

When was uMI Panorama approved by the FDA?

uMI Panorama received FDA 510(k) clearance on 2023-03-10, under approval number K223325.

What company makes uMI Panorama?

uMI Panorama is manufactured by Shanghai United Imaging Healthcare Co., Ltd..

What is the FDA product code for uMI Panorama?

The FDA product code for uMI Panorama is KPS.

Other Devices by Shanghai United Imaging Healthcare Co., Ltd.

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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.