uCT 780
K241079Shanghai United Imaging Healthcare Co., Ltd. · cleared 2025-01-07 · product code JAK · Radiology
Premarket evidence — what FDA accepted
source quote (p.6)
“The Computed Tomography X-ray System, uCT 780, 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 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. ... The DELTA (Deep Recon) is an AI-based reconstruction method that deployed within uCT 780 acquisition and processing software.”
source quote (p.7)
“The DELTA (Deep Recon) is an AI-based reconstruction method that deployed within uCT 780 acquisition and processing software. ... AI-based deep learning reconstruction algorithm.”
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; CT HU number test and thickness section test based on water phantom and Catphan 700 phantom; Noise power spectrum test was applied on water phantom for more comprehensive test on DELTA; Mean CT value test on CT Whole Body Phantom PBU-60 phantom was applied to comparing mean HU value of different clinical relevant tissue between FBP and DELTA; 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 high contrast spatial resolution enhanced comparing with FBP
standards: IEC 61223-3-5, MITA CCT189, MITA CCT191
Reader study (MRMC)
n=60 patients
endpoints: noise; structure fidelity; 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
- 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
- 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
- …and 6 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).