uCT ATLAS with uWS-CT-Dual Energy Analysis

K203448

Shanghai United Imaging Healthcare Co., Ltd. · cleared 2021-08-11 · product code JAK · Radiology

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.5)
“The new generation reconstruction method, Deep IR (also named AIIR), which combines the model-based iterative reconstruction and deep learning technology together, in order to reduce image noise and artifacts, while at the same time improving low contrast detectability and spatial resolution”
Algorithmmodel-based iterative reconstruction and deep learning technology
source quote (p.5)
“The new generation reconstruction method, Deep IR (also named AIIR), which combines the model-based iterative reconstruction and deep learning technology together, in order to reduce image noise and artifacts, while at the same time improving low contrast detectability and spatial resolution”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.12)
“UNITED IMAGING HEALTHCARE conforms to the Cybersecurity requirements by implementing a process of preventing unauthorized access, modification, misuse or denial of use, or unauthorized use of information that is stored, accessed, or transferred from a medical device to an external recipient. Cybersecurity information in accordance with guidance document “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices” is included in this submission.”

Validation studies (1)

Bench

sample size not stated

standards: ES 60601-1:2005(R)2012+A1:2012+C1:2009/(R)2012+A2:2010/(R)2012 Medical electrical equipment Part 1: General requirements for basic safety and essential performance, IEC 60601-2-44 Edition 3.2: 2016 Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of x-ray equipment for computed tomography, IEC 60601-1-2 Edition 4.0 2014-02 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and testsIEC 60825-1 Edition 2.0 2007-03, Safety Of Laser Products - Part 1: Equipment Classification, And Requirements [Including: Technical Corrigendum 1 (2008), Interpretation Sheet 1 (2007), Interpretation Sheet 2 (2007)], NEMA XR 25-2019, Computed Tomography Dose Check, NEMA XR 28-2018, Supplemental Requirements For User Information And System Function Related To Dose In CT, NEMA XR 29-2013, Standard Attributes on CT Equipment Related to Dose Optimization and Management, IEC 60601-1-3 Edition 2.1 2013-04, Medical Electrical Equipment - Part 1-3:, IEC 61223-3-5 First Edition 2004-08, Evaluation And Routine Testing In Medical Imaging Departments - Part 3-5: Acceptance Tests - Imaging Performance Of Computed Tomography X-ray Equipment [Including: Technical Corrigendum 1 (2006)], NEMA PS 3.1-3.20(2016): Digital Imaging and Communications in Medicine (DICOM), IEC 62304: Medical Device Software - software life cycle process, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, ISO 10993-5 Third Edition 2009-06-01, Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity, ISO 10993-10 Third Edition 2010-08-01, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization, ISO 14971: Medical Devices – Application of risk management to medical devices, Code of Federal Regulations, Title 21, Part 820 - Quality System Regulation, Code of Federal Regulations, Title 21, Subchapter J - Radiological Health, Laser Products - Conformance with IEC 60825-1 and IEC 60601-2-22; Guidance for Industry and FDA Staff (Laser Notice No. 50), Provision for Alternate Measure of the Computed Tomography Dose Index (CTDI) to Assure Compliance with the Dose Information Requirements of the Federal Performance Standard for Computed Tomography

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

75
recalls in product code, 24mo
192
MAUDE reports in code, 12mo
-22%
vs code's own 3-yr baseline
14
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

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K241166 (decision 2025-01-14) from Shanghai United Imaging Healthcare Co., Ltd. for a matching device line ("uCT 550") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K241166

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K241079 (decision 2025-01-07) from Shanghai United Imaging Healthcare Co., Ltd. for a matching device line ("uCT 780") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K241079

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K223028 (decision 2023-02-16) from Shanghai United Imaging Healthcare Co., Ltd. for a matching device line ("uCT ATLAS Astound with uWS-CT-Dual Energy Analysis") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K223028

  • 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

  • …and 8 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/K203448