uDR 780i
K-Number: K241068 · 2024-11-01
Decision Date2024-11-01
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
uDR 780i is a medical device manufactured by Shanghai United Imaging Healthcare Co., Ltd.. It received FDA 510(k) clearance on 2024-11-01 under approval 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. It is manufactured by Shanghai United Imaging Healthcare Co., Ltd.. The 510(k) number is K241068.
When was uDR 780i approved by the FDA?
uDR 780i received FDA 510(k) clearance on 2024-11-01, under approval number K241068.
What company makes uDR 780i?
uDR 780i is manufactured by Shanghai United Imaging Healthcare Co., Ltd..
What is the FDA product code for uDR 780i?
The FDA product code for uDR 780i is KPR.
Other Devices by Shanghai United Imaging Healthcare Co., Ltd.
Related Devices (Code: KPR)
K163203Carestream DRX-EvolutionCarestream Health, Inc.
K163115GC70Samsung Electronics Co., Ltd.
K152813FS-500DDR Medical Radiographic X-Ray SystemOrich Medical Equipment (Tianjin) Co., Ltd.
K162971Multix Fusion MaxSiemens Medical Solutions USA, Inc.
K161937CuattroDRCuattro, LLC
K162224ArtPix Mobile EZ2GOCmt Medical Technologies, 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.