uCT 550

The uCT 550 is a Class II Computed Tomography X-ray system designed to generate cross-sectional body images using computer reconstruction of X-ray transmission data. Its efficacy and safety, including enhanced image quality and dose reduction through the DELTA (Deep Recon) algorithm, were established through bench and clinical evaluations, leading to a determination of substantial equivalence to predicate devices.

The uCT 550, a Class II Computed Tomography (CT) X-ray system developed by Shanghai United Imaging Healthcare Co., Ltd., has received regulatory clearance. This device is specifically engineered to produce detailed cross-sectional images of the human body by employing computer reconstruction techniques on acquired X-ray transmission data. Its approval stems from a determination of substantial equivalence to other CT systems already legally marketed, affirming its intended use for diagnostic imaging. Supporting its marketing authorization, the uCT 550 underwent comprehensive performance evaluations, encompassing both bench and clinical studies. These assessments particularly highlighted the efficacy of its proprietary DELTA (Deep Recon) algorithm, which demonstrated improvements in image quality while simultaneously contributing to dose reduction. Adherence to a multitude of safety and quality standards further substantiated the conclusion that the uCT 550 possesses a safety and effectiveness profile comparable to its predicate devices, although its continued market presence remains contingent upon ongoing compliance with regulatory requirements such as annual registration, device listing, and good manufacturing practices.

AI Regulatory Concerns

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Jev reads the full FDA letter and returns calibrated concern probabilities per regulatory category. These are AI estimates, not regulatory advice.

• Q1. How does the DELTA (Deep Recon) algorithm specifically achieve both improved image quality and dose reduction compared to conventional reconstruction methods?; What were the specific clinical evaluation protocols and patient cohorts used to demonstrate the uCT 550's safety and effectiveness profile?; Beyond substantial equivalence, are there any unique technical specifications or features of the uCT 550 that differentiate it from its predicate devices?; What long-term post-market surveillance data is planned or being collected to monitor the uCT 550's performance, particularly regarding image artifact reduction and dose optimization in routine clinical use?; What are the specific thresholds or criteria for device changes that would necessitate a new premarket submission for the uCT 550?