uCT ATLAS Astound with uWS-CT-Dual Energy Analysis; uCT ATLAS with uWS-CT-Dual Energy Analysis

K243617

Shanghai United Imaging Healthcare Co.,Ltd. · cleared 2025-05-16 · product code JAK · Radiology

Premarket evidence — what FDA accepted

Device typehardware with ml

source quote (p.4)

“uCT ATLAS Astound is a computed tomography x-ray system, which is intended to produce cross-sectional images of the whole body by computer reconstruction of x-ray transmission data taken at different angles and planes. uWS-CT-Dual Energy Analysis is a post-processing software package that accepts UIH CT images acquired using different tube voltages and/or tube currents of the same anatomical location. It is an image reconstruction method for cardiac scanning based on deep learning technology.”

Algorithmdeep learning technology, modal-based iterative reconstruction and deep learning technology, deep learning network optimization

source quote (p.9)

“It is an image reconstruction method for cardiac scanning based on deep learning technology. It is an image reconstruction method that combines a modal-based iterative reconstruction and deep learning technology.”

Adaptive (vs locked)No

PCCPNo

Cybersecurity addressedNo

Validation studies (10)

Bench

sample size not stated

endpoints: General IQ Performance testing; CT HU number test; thickness section test; low contrast detectability (LCD) test; LCD enhancement; dose reduction; noise reduction; high contrast spatial resolution test

standards: IEC 61223-3-5, CTIQ White Paper, AAPM's report

Bench

sample size not stated

standards: IEC 61223-3-5, CTIQ White Paper, AAPM's report

Bench

sample size not stated

endpoints: extraction accuracy of new AI module in heart and coronary artery structure; Dice Similarity Coefficient (DICE); Precision; Recall

Bench

sample size not stated

endpoints: effectiveness on reducing head motion artifacts

Bench

sample size not stated

endpoints: effectiveness on improving CT value accuracy; improving the CT number

Reader study (MRMC)

sample size not stated

endpoints: image quality aspects; noise level; structure fidelity; image quality; clinical features

Reader study (MRMC)

sample size not stated

endpoints: image quality aspects; noise level; streaking artifact reduction; image structure fidelity

Reader study (MRMC)

sample size not stated

endpoints: image quality aspects; artifact correction effect; clinical diagnostic benefit

Reader study (MRMC)

sample size not stated

endpoints: image quality aspects; image artifacts; homogeneity of same tissue

Reader study (MRMC)

sample size not stated

endpoints: Contours are clear and continuous; Motion artifacts of coronary arteries are tolerable; Number of diagnostic coronaries reaches at least 50% of the total number of coronary artery segments

Reported performance (3 observations)

diceas written: “Dice Similarity Coefficient (DICE)”stated without value

source quote (p.12)

“The quantitative assessment metrics for the heart mask and coronary artery mask extracted by the new AI module and the annotated results are calculated: Dice Similarity Coefficient (DICE), Precision, and Recall.”

ppvas written: “Precision”stated without value

source quote (p.12)

“The quantitative assessment metrics for the heart mask and coronary artery mask extracted by the new AI module and the annotated results are calculated: Dice Similarity Coefficient (DICE), Precision, and Recall.”

sensitivityas written: “Recall”stated without value

source quote (p.12)

“The quantitative assessment metrics for the heart mask and coronary artery mask extracted by the new AI module and the annotated results are calculated: Dice Similarity Coefficient (DICE), Precision, and Recall.”

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
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
recall_reason_pattern
Software/algorithm-related recall in product code JAK (Philips North America Llc, initiated 2025-05-29): "Devices with affected software may experience two unintended motion issues that may lead to contact between the Gantry or table with the operator or patient, along with additional " Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:97010
…and 4 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).