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FDA 510(k)

uDR 780i

K-Number: K241068 · 2024-11-01

Decision Date2024-11-01
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

uDR 780i 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 2024-11-01 under 510(k) number K241068. 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 780i?

uDR 780i is a medical device that received FDA 510(k) clearance on 2024-11-01. The listed applicant is Shanghai United Imaging Healthcare Co., Ltd.. The 510(k) number is K241068.

When did uDR 780i receive FDA 510(k) clearance?

uDR 780i received FDA 510(k) clearance on 2024-11-01, under 510(k) number K241068.

Who is the listed applicant for uDR 780i?

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 780i?

The FDA product code for uDR 780i 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.

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.

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.