uCT 780

K241079

Shanghai United Imaging Healthcare Co., Ltd. · cleared 2025-01-07 · product code JAK · Radiology

Premarket evidence — what FDA accepted

Device typehardware with ml
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.”
AlgorithmAI-based deep learning reconstruction algorithm
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.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (2)

Bench

sample size not stated

endpoints: dose reduction; LCD; noise; spatial resolution; HU value; noise power spectrum; image quality

standards: IEC 61223-3-5

Reader study (MRMC)

n=60 cases

endpoints: noise; structure fidelity; overall image quality; mean score of simulated low dose DELTA image is equal or higher than the mean score of normal dose FBP; mean score of DELTA is better than the mean score of FBP under same dose; DELTA can have satisfy diagnosis requirement in all the evaluated image

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
12
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

  • 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); 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/K241079