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 for image reconstruction, motion correction, and phase recommendation.
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. It can recommend the optimal phase for cardiac reconstruction, which is based on deep learning technology. It is an intelligent function based on deep learning to reduce the artifacts caused by head motion. It can extend reconstruction FOV to bore size using deep learning technique. It is a motion correction function for cardiac scanning to reduce coronary motion artifact, which is based on deep learning technology.”
Adaptive (vs locked)No
PCCPNo
Cybersecurity addressedNo

Validation studies (10)

Bench

sample size not stated

endpoints: IQ Performance (CT HU number, thickness section); Low Contrast Detectability (LCD); High Contrast Spatial Resolution; Noise

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

Bench

sample size not stated

endpoints: IQ Performance (CT HU number, thickness section); Low Contrast Detectability (LCD); High Contrast Spatial Resolution; Noise

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

Bench

sample size not stated

endpoints: Extraction accuracy of 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 CT number when scanned object exceeds FOV

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); Accuracy of image CT numbers

Reader study (MRMC)

sample size not stated

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

Reported performance (1 observation)

accuracyas written: “Ultra EFOV CT Number Accuracy (Reader Study)”stated without value
source quote (p.13)
“The results confirm that the images with Ultra EFOV can improve the accuracy of image CT numbers, in cases where the scanned object exceeds the CT field of view.”

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

75
recalls in product code, 24mo
192
MAUDE reports in code, 12mo
-22%
vs code's own 3-yr baseline
10
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); a recall is shown as device-attributed only when the recall record itself lists this clearance number. 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).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K243617