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FDA 510(k)

uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES)

K-Number: K253564 · 2026-02-13

ApplicantShanghai United Imaging Healthcare Co., Ltd.
Decision Date2026-02-13
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES) is a medical device manufactured by Shanghai United Imaging Healthcare Co., Ltd.. It received FDA 510(k) clearance on 2026-02-13 under approval number K253564. 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 Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES)?

uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES) is a medical device that received FDA 510(k) clearance on 2026-02-13. It is manufactured by Shanghai United Imaging Healthcare Co., Ltd.. The 510(k) number is K253564.

When was uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES) approved by the FDA?

uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES) received FDA 510(k) clearance on 2026-02-13, under approval number K253564.

What company makes uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES)?

uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES) is manufactured by Shanghai United Imaging Healthcare Co., Ltd..

What is the FDA product code for uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES)?

The FDA product code for uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES) is KPS.

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

K182938Emission Computed Tomography System K173001uWS-CT K172999uWS-MR K182237uMI 550 PET/CT System K181371uMR 790 K181370uMR 780

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Related Devices (Code: KPS)

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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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