uCT ATLAS Astound with uWS-CT-Dual Energy Analysis
K223028Shanghai United Imaging Healthcare Co., Ltd. · cleared 2023-02-16 · product code JAK · Radiology
Premarket evidence — what FDA accepted
source quote (p.5)
“The proposed device uCT ATLAS Astound with uWS-CT-Dual Energy Analysis includes image acquisition hardware, image acquisition, reconstruction and dual energy analysis software, and associated accessories. 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”
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”
source quote (p.11)
“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 (2)
Bench
sample size not stated
standards: ANSI AAMI ES60601-1:2005+A1:2012+A2:2021, IEC 60601-1-2: 2014, Edition 4.0, IEC 60601-1-3: 2008+AMD1:2013+A2:2021, IEC 60601-2-44 Edition 3.2: 2016, IEC 60601-1-6:2010+A1:2013+A2:2020, NEMA XR 25-2019, NEMA XR 28-2018, NEMA XR 29-2013, IEC 61223-3-5 First Edition 2004-08, NEMA PS 3.1-3.20(2016), 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: 2009, Edition 3.0, ISO 10993-10: 2010, Edition 3.0, ISO 14971: 2019, Edition 3.0, Code of Federal Regulations, Title 21, Part 820, Code of Federal Regulations, Title 21, Subchapter J, 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, Laser Product - Conformance with IEC 60825-1; Guidance for Industry and FDA Staff (Laser Notice No. 56)
Reader study (MRMC)
sample size not stated
endpoints: image quality are sufficient for clinical diagnosis
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
- 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
- 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
- …and 7 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).