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FDA 510(k)

uDR Arria & uDR Aris

K-Number: K252000 · 2025-11-26

ApplicantShanghai United Imaging Healthcare Co., Ltd.
Decision Date2025-11-26
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

uDR Arria & uDR Aris 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 2025-11-26 under 510(k) number K252000. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the uDR Arria & uDR Aris?

uDR Arria & uDR Aris is a medical device that received FDA 510(k) clearance on 2025-11-26. The listed applicant is Shanghai United Imaging Healthcare Co., Ltd.. The 510(k) number is K252000.

When did uDR Arria & uDR Aris receive FDA 510(k) clearance?

uDR Arria & uDR Aris received FDA 510(k) clearance on 2025-11-26, under 510(k) number K252000.

Who is the listed applicant for uDR Arria & uDR Aris?

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 uDR Arria & uDR Aris?

The FDA product code for uDR Arria & uDR Aris is KPR.

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 Devices (Code: KPR)

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.

K260482DRE DuoJpi Healthcare Co, Ltd.K253446AeroDR TX c02Dk Medical Systems Co., Ltd.K250954DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detectorCarestream HealthK251167uDR Aurora CXShanghai United Imaging Healthcare Co., Ltd.K250788Definium Tempo SelectGe Hualun Medical Systems Co. , Ltd.K250790INNOVISION-DXIIDk Medical Systems Co., Ltd.

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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