uCT 550

K241166

Shanghai United Imaging Healthcare Co., Ltd. · cleared 2025-01-14 · product code JAK · Radiology

Premarket evidence — what FDA accepted

Device typehardware with ml

source quote (p.6)

“The Computed Tomography X-ray system, uCT 550, is intended to produce cross-sectional images of the patient by computer reconstruction of X-ray transmission data taken at different angles and planes. The proposed device consists of CT scan gantry (including high voltage generator, X-ray tube, collimator and detectors), patient table, operating console (including console PC, monitor and Control Box), power supply cabinet (PSC), vital signal monitoring gated control unit (VSM), 3D camera, system software, and accessories. It is an AI-based deep learning algorithm to effectively reduce image noise, enhance high-contrast spatial resolution, improve low-contrast detectability, and correspondingly decrease the dose required for diagnostic CT images.”

AlgorithmAI-based deep learning algorithm

source quote (p.9)

“It is an AI-based deep learning algorithm to effectively reduce image noise, enhance high-contrast spatial resolution, improve low-contrast detectability, and correspondingly decrease the dose required for diagnostic CT images.”

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedYes

source quote (p.15)

“Content of Premarket Submissions for Management of Cybersecurity in Medical Devices”

Validation studies (2)

Bench

sample size not stated

endpoints: General IQ Performance testing of metrics identified in IEC 61223-3-5 to study overall performance in a standardized and referenceable manner. General IQ tests include CT HU number test and thickness section test based on water phantom and Catphan 700 phantom.; A low contrast detectability (LCD) test was performed to evaluate the LCD enhancement, dose reduction and noise reduction on MITA CCT189 and MITA CCT191 phantom.; A high contrast spatial resolution test was performed under the guidance of IEC 61223-3-5 to evaluate the improvement of high contrast spatial resolution compared with FBP.

standards: IEC 61223-3-5, MITA CCT189, MITA CCT191

Reader study (MRMC)

n=44 cases

endpoints: The image quality was scored by different board-certified U.S. radiologists to perform a five-point scale evaluation of both image sets on three image quality aspects: noise, image structure fidelity and overall image quality.

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.

Predicate network

Postmarket — what happened after clearance

recalls in product code, 24mo

192

MAUDE reports in code, 12mo

-22%

vs code's own 3-yr baseline

drift signals on this device

re_clearance
The FDA AI/ML device list shows a newer 510(k) K253173 (decision 2026-01-20) from Shanghai United Imaging Healthcare Co., Ltd. for a matching device line ("uCT 780 with uWS-CT-Dual Energy Analysis") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K253173
re_clearance
The FDA AI/ML device list shows a newer 510(k) K243617 (decision 2025-05-16) from Shanghai United Imaging Healthcare Co.,Ltd. for a matching device line ("uCT ATLAS Astound with uWS-CT-Dual Energy Analysis; uCT ATLAS with uWS-CT-Dual Energy Analysis") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K243617
recall_reason_pattern
Software/algorithm-related recall in product code JAK (GE Medical Systems, LLC, initiated 2026-03-26): "GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with " Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:98738
recall_reason_pattern
Software/algorithm-related recall in product code JAK (PHILIPS MEDICAL SYSTEMS, initiated 2026-03-07): "Philips has identified three software issues: 1. During a continuous CT (CCT) scan, there is the potential that the Gantry could remain at the current scan position after pressing" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:98588
recall_reason_pattern
Software/algorithm-related recall in product code JAK (Siemens Medical Solutions USA, Inc, initiated 2025-12-19): "To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance." Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:98206
recall_reason_pattern
Software/algorithm-related recall in product code JAK (PHILIPS MEDICAL SYSTEMS, initiated 2025-09-25): "Issue 1: The potential for unintentional continued gantry/couch movement when a specific button series is used requiring use of manual stop. Issue 2. When performing a helical/Axia" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:97699
…and 5 more.

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).