uCT 550
K-Number: K241166 · 2025-01-14
Decision Date2025-01-14
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
uCT 550 is a medical device manufactured by Shanghai United Imaging Healthcare Co., Ltd.. It received FDA 510(k) clearance on 2025-01-14 under approval number K241166. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the uCT 550?
uCT 550 is a medical device that received FDA 510(k) clearance on 2025-01-14. It is manufactured by Shanghai United Imaging Healthcare Co., Ltd.. The 510(k) number is K241166.
When was uCT 550 approved by the FDA?
uCT 550 received FDA 510(k) clearance on 2025-01-14, under approval number K241166.
What company makes uCT 550?
uCT 550 is manufactured by Shanghai United Imaging Healthcare Co., Ltd..
What is the FDA product code for uCT 550?
The FDA product code for uCT 550 is JAK.
Other Devices by Shanghai United Imaging Healthcare Co., Ltd.
Related Devices (Code: JAK)
K162302Somatom Confidence ® RT ProSiemens Medical Solutions USA, Inc.
K163213Revolution CTGe Medical Systems, LLC
K161157Vitrea CT Dual Energy Image ViewVital Images, Inc.
K160723OnSight 3D Extremity SystemCarestream Health, Inc.
K161196SOMATOM DriveSiemens Medical Solutions USA, Inc.
K161748SUPRIA w/guideShot OptionHitachi Medical Systems America, Inc.
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.