Authorized purpose: uCT 780 produces whole-body cross-sectional CT images, including head, neck, cardiac, and vascular imaging, supports protocol-governed low-dose lung cancer screening and dual-energy material visualization, and uses DELTA deep-learning reconstruction for adult head, chest, abdomen, cardiac, and vascular applications.
Evidence status: each field states its source quality, applicability, and review date. Research pending, information not established, and vendor documentation pending remain distinct outcomes.
Product overview
Start with the essentials
Authorized purpose: uCT 780 produces whole-body cross-sectional CT images, including head, neck, cardiac, and vascular imaging, supports protocol-governed low-dose lung cancer screening and dual-energy material visualization, and uses DELTA deep-learning reconstruction for adult head, chest, abdomen, cardiac, and vascular applications.
Overview status: Source-reviewed overview
What does this software do?Authorized purpose: uCT 780 produces whole-body cross-sectional CT images, including head, neck, cardiac, and vascular imaging, supports protocol-governed low-dose lung cancer screening and dual-energy material visualization, and uses DELTA deep-learning reconstruction for adult head, chest, abdomen, cardiac, and vascular applications.
Which images or clinical context are in scope?Modality: CT/CTA Anatomy or clinical context: Multi-region Input: CT projection data acquired on uCT 780; uWS-CT-Dual Energy Analysis accepts United Imaging CT images of the same anatomy acquired at different tube voltages and currents.
Who uses it?Intended users: A consultation with a radiologist and a physicist should be made to determine the appropriate dose to obtain diagnostic image quality for the particular clinical task; clinicians or dosimetrists should only be allowed to reduce patient dose in clinical practice.
What does the software produce?Output: Cross-sectional CT images reconstructed with FBP or DELTA and dual-energy material, chemical, and multiple-energy visualizations for qualified-user review.
What is its most important limitation?Key limitation: The FDA summary states that the submitted clinical study alone cannot support promotional claims that DELTA achieves equivalent or better image quality; additional testing is needed for such claims. A radiologist and physicist should determine appropriate dose for each diagnostic task, only clinicians or dosimetrists should reduce dose, and DELTA was not thoroughly tested in pediatric patients. Low-dose lung cancer screening must follow an approved and published screening program.
Clinical takeaway
Clinical role: uCT 780 produces whole-body cross-sectional CT images, including head, neck, cardiac, and vascular imaging, supports protocol-governed low-dose lung cancer screening and dual-energy material visualization, and uses DELTA deep-learning reconstruction for adult head, chest, abdomen, cardiac, and vascular applications.
Evidence takeaway
Evidence from the reviewed source record: FDA-reviewed manufacturer evidence includes phantom testing and a 60-subject, two-reader clinical image-quality program with separated training, validation, and test data. The reported acceptance criteria were met, but FDA explicitly limits promotional interpretation and the evidence does not establish patient outcomes.
Clinical details
What this tool is for
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
Exact purpose
uCT 780 produces whole-body cross-sectional CT images, including head, neck, cardiac, and vascular imaging, supports protocol-governed low-dose lung cancer screening and dual-energy material visualization, and uses DELTA deep-learning reconstruction for adult head, chest, abdomen, cardiac, and vascular applications.
FDA source
Exact FDA submission
Checked 2026-09-19
Clinical-use display mirrors the exact FDA-supported purpose reconciled from the decision-summary packet.
A consultation with a radiologist and a physicist should be made to determine the appropriate dose to obtain diagnostic image quality for the particular clinical task; clinicians or dosimetrists should only be allowed to reduce patient dose in clinical practice.
FDA source
Exact FDA submission
Checked 2026-09-19
This replaces the broader current clinician and imaging-staff label with the packet's direct dose-management user conditions.
Professional healthcare facilities performing diagnostic CT, cardiac and vascular CT, dual-energy analysis, and protocol-governed lung cancer screening.
Acquires and reconstructs CT examinations, applies DELTA at one of five noise-reduction levels, and supports dual-energy analysis by combining low- and high-energy acquisitions of the same anatomy to visualize material or chemical information and multiple-energy images.
CT projection data acquired on uCT 780; uWS-CT-Dual Energy Analysis accepts United Imaging CT images of the same anatomy acquired at different tube voltages and currents.
FDA source
Exact FDA submission
Checked 2026-09-19
Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.
Cross-sectional CT images reconstructed with FBP or DELTA and dual-energy material, chemical, and multiple-energy visualizations for qualified-user review.
FDA source
Exact FDA submission
Checked 2026-09-19
Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.
The FDA summary states that the submitted clinical study alone cannot support promotional claims that DELTA achieves equivalent or better image quality; additional testing is needed for such claims. A radiologist and physicist should determine appropriate dose for each diagnostic task, only clinicians or dosimetrists should reduce dose, and DELTA was not thoroughly tested in pediatric patients. Low-dose lung cancer screening must follow an approved and published screening program.
FDA source
Exact FDA submission
Checked 2026-09-19
Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.
The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.
The packet explicitly identifies uCT 780 as a computed tomography x-ray system; the current dossier modality is null. Controlled directory display reconciled from exact FDA wording: Computed tomography x-ray system. -> CT/CTA.
Use these fields to structure a vendor demo, security review, and implementation estimate.
Integration
DELTA is deployed within the uCT 780 acquisition and image-processing software. The uWS dual-energy application consumes compatible United Imaging CT image sets acquired at two energy settings for the same anatomy.
FDA source
Exact FDA submission
Checked 2026-09-02
Confirm DICOM services, workstation topology, PACS routing, series pairing, quantitative-map handling, licensing, and downstream compatibility for the installed release.
FDA authorization does not establish the current commercial security posture. Request data-flow diagrams, hosting and retention details, access controls, audit logging, attestations, and incident-response documentation.
Training and support
Vendor documentation pending
Vendor confirmation
Exact FDA submission
Checked 2026-08-13
Training, onboarding, competency, and support commitments are commercial implementation details that require current vendor documentation.
Monitoring and change control
Vendor documentation pending
Vendor confirmation
Exact FDA submission
Checked 2026-08-13
Local acceptance testing, production monitoring, drift review, update control, and incident escalation require a current vendor and site-specific governance plan.
DELTA reconstruction controls
DELTA deep-learning reconstruction is embedded in uCT 780 acquisition and processing software for adult head, chest, abdomen, cardiac, and vascular CT and provides five selectable noise-reduction levels.
exact submission · checked 2026-09-02
Validate each protocol, dose target, reconstruction level, artifact pattern, and fallback with radiologist and physicist oversight before routine use.
uWS-CT-Dual Energy Analysis combines compatible low- and high-energy United Imaging CT image sets from the same anatomy to provide material, chemical, and multiple-energy visualizations.
The FDA summary directs sites to consult a radiologist and physicist for task-specific dose selection and limits dose reduction decisions to clinicians or dosimetrists.
exact submission · checked 2026-09-02
Include protocol approval, change control, pediatric restrictions, audit logging, and periodic image-quality review in implementation governance.
United Imaging's current uCT 780 family page presents DELTA reconstruction and spectral and perfusion options, but commercial specifications and options may span configurations or software releases.
product family · checked 2026-09-02
Map every quoted feature, hardware option, interface, service level, and price to the exact installed configuration.
Metrics are shown only when they are tied to a source, endpoint, population, and tested product version. Candidate literature without exact product and version linkage is not shown as product evidence.
Evidence summary
FDA-reviewed manufacturer evidence includes phantom testing and a 60-subject, two-reader clinical image-quality program with separated training, validation, and test data. The reported acceptance criteria were met, but FDA explicitly limits promotional interpretation and the evidence does not establish patient outcomes.
DesignManufacturer-sponsored image-quality study with two U.S. board-certified radiologists using five-point ratings for noise, structure fidelity, and overall image quality
Population60 subjects total: 20 validation cases with five each from abdomen, chest, head, and cardiac examinations, plus 40 test cases with ten per body part across different dose levels
Scopeexact submission
Tested versionDELTA on uCT 780 cleared in K241079
Samplen=60
IndependenceSponsor or vendor study
K241079
Training data were excluded from validation and test sets. FDA reports that criteria were met but explicitly states that this study alone cannot support promotional equivalence or superiority claims.
These are common procurement questions; unknown values remain visible until a source supports them.
Pricing and total cost
Vendor documentation pending
Vendor confirmation
Exact FDA submission
Checked 2026-08-13
FDA submission materials do not establish current commercial pricing. Request the pricing unit, term, minimum commitment, implementation fees, and included support from the vendor.
Reimbursement and coding
Research pending
Needs research
Exact FDA submission
Checked 2026-08-31
Determine whether any product-specific CPT/HCPCS pathway exists and separate it from billing for the underlying imaging service.
Safety and lifecycle
Postmarket record
Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.
Postmarket safety review
FDA recall Z-0220-2026 affects uCT 780 systems. A third-party outer cover could become trapped between the patient table and gantry and interfere with table movement. FDA lists the recall as open and classified.
FDA source
Exact FDA submission
Checked 2026-09-04
Each published event was manually matched to the exact FDA submission and affected product or version; a recall does not establish an AI-algorithm defect or current site exposure unless the event states that scope.
Verify security and privacy controls: FDA authorization does not establish the current commercial security posture. Request data-flow diagrams, hosting and retention details, access controls, audit logging, attestations, and incident-response documentation.
Verify training: Training, onboarding, competency, and support commitments are commercial implementation details that require current vendor documentation.
Verify pricing and total cost: FDA submission materials do not establish current commercial pricing. Request the pricing unit, term, minimum commitment, implementation fees, and included support from the vendor.
Verify reimbursement and coding relevance: Determine whether any product-specific CPT/HCPCS pathway exists and separate it from billing for the underlying imaging service.
Verify local validation and lifecycle monitoring: Local acceptance testing, production monitoring, drift review, update control, and incident escalation require a current vendor and site-specific governance plan.
This audit distinguishes completed source review from fields that have not yet been researched.
Human reviewedStatus
2026-09-04Last searched
24Fields reviewed
10Source classes checked
1Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads
The refreshed discovery snapshot contains 1 PubMed and 0 ClinicalTrials.gov candidate record. Discovery metadata alone does not establish exact tested-product, version, population, and endpoint applicability, so all candidates remain quarantined and none was promoted. The current discovery snapshot contains 1 PubMed and 0 ClinicalTrials.gov candidate records; its dated, count-matched human screening remains current. Unlinked candidates remain quarantined. 1 FDA recall candidate was manually reviewed: 1 published and 0 rejected as a neighboring or otherwise inapplicable version. Native FDA recall identifiers produced 1 postmarket candidate record; 1 has been reviewed (1 published, 0 rejected) and 0 remain unreviewed.
Candidate leads were screened against the exact product and tested version. Unlinked records remain quarantined.
Source classes: fda ai list, fda decision summary, fda device recall, vendor product page, fda decision summary packet, literature index, trial registry, pubmed, clinical trials, openfda device recall
Sources & history
How this profile was documented
Open the ledger for source dates, scope, and research-record updates.
View source ledger and history7 sources - 3 history items
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