Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

uDR Aurora CX

K-Number: K251167 · 2025-09-19

ApplicantShanghai United Imaging Healthcare Co., Ltd.
Decision Date2025-09-19
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

uDR Aurora CX 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 2025-09-19 under 510(k) number K251167. 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 Aurora CX?

uDR Aurora CX is a medical device that received FDA 510(k) clearance on 2025-09-19. The listed applicant is Shanghai United Imaging Healthcare Co., Ltd.. The 510(k) number is K251167.

When did uDR Aurora CX receive FDA 510(k) clearance?

uDR Aurora CX received FDA 510(k) clearance on 2025-09-19, under 510(k) number K251167.

Who is the listed applicant for uDR Aurora CX?

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 Aurora CX?

The FDA product code for uDR Aurora CX 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

View all 84 devices →

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 HealthK252000uDR Arria & uDR ArisShanghai 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.

↑