uMI Panorama combines PET and 160-slice CT to provide quantitative radiopharmaceutical distribution, diagnostic anatomical and attenuation information, and registered or fused PET/CT images supporting detection, localization, diagnosis, staging, restaging, treatment planning, and treatment-response evaluation in oncology, cardiology, neurology, inflammation, infection, and other disorders. The CT subsystem can also perform standalone diagnostic imaging and protocol-governed low-dose lung cancer screening.
Evidence status: each field shows source quality, applicability, and review date. Research pending, information not established in reviewed sources, and vendor documentation pending are distinct outcomes.
Clinical fit
What this tool is for
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
Exact purpose
uMI Panorama combines PET and 160-slice CT to provide quantitative radiopharmaceutical distribution, diagnostic anatomical and attenuation information, and registered or fused PET/CT images supporting detection, localization, diagnosis, staging, restaging, treatment planning, and treatment-response evaluation in oncology, cardiology, neurology, inflammation, infection, and other disorders. The CT subsystem can also perform standalone diagnostic imaging and protocol-governed low-dose lung cancer screening.
FDA source Exact FDA submission Checked 2026-09-02
Supports patient and examination management, PET and CT data acquisition, image reconstruction, display and post-processing, quantitative PET review, PET/CT registration and fusion, networking, and filming. uExcel DPR uses pretrained neural networks for PET denoising and contrast improvement, while uExcel Focus and HYPER Focus address respiratory-motion effects.
FDA source Exact FDA submission Checked 2026-09-02
PET coincidence data from administered radiopharmaceuticals and CT X-ray transmission data acquired on uMI Panorama 28 or 35; respiratory-motion workflows use the system's supported acquisition and reconstruction inputs.
FDA source Exact FDA submission Checked 2026-09-02
Quantitative PET images, diagnostic and attenuation-correction CT images, registered or fused PET/CT images, and motion-corrected PET reconstructions with lesion-volume and standardized-uptake-value information for qualified-user review.
FDA source Exact FDA submission Checked 2026-09-02
Use is restricted to qualified healthcare professionals. Low-dose CT lung cancer screening must follow an approved and published screening program, and available reconstruction or motion-correction features depend on the installed system and configuration. The FDA summary reports non-clinical testing but no clinical outcomes study.
FDA source Exact FDA submission Checked 2026-09-02
The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.
FDA submission
K223325
FDA source Exact FDA submission Checked 2026-08-31
Use these fields to structure a vendor demo, security review, and implementation estimate.
Integration
The scanner control and reconstruction environment provides data and patient management, networking, display and post-processing, and DICOM-standard image exchange.
FDA source Exact FDA submission Checked 2026-09-02
Confirm supported DICOM services, object types, PACS and RIS connectivity, worklist behavior, and interface versions for the installed configuration.
Vendor confirmation Exact FDA submission Checked 2026-08-13
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.
Scanner configuration
Integrated PET and 160-slice CT system with 280 mm or 350 mm PET axial field of view, a 760 mm bore, and a maximum table load of 318 kg.
exact submission · checked 2026-09-02
Confirm ordered detector coverage, table accessories, room requirements, power, cooling, shielding, and service clearances.
Provides DICOM-standard image exchange plus patient and data management, networking, image display, post-processing, and filming functions within the scanner environment.
exact submission · checked 2026-09-02
Validate modality worklist, accession and patient reconciliation, PACS routing, quantitative-image preservation, and downstream viewer compatibility.
United Imaging's current uMI Panorama family page describes 28 cm and 35 cm scalable PET axial fields of view, a 76 cm bore, 318 kg table capacity, 160 CT slices per rotation, and uExcel AI workflow features.
product family · checked 2026-09-02
Current family-page claims may span configurations or software releases; map them to the quoted and installed system before procurement or validation.
Metrics are shown only when they are tied to a source, endpoint, population, and tested product version.
Evidence summary
FDA-reviewed support consists of manufacturer non-clinical dosimetry, image-performance, software, and system testing. No independent clinical outcomes study is reported in the 510(k) summary.
FDA source Exact FDA submission Checked 2026-09-02
Needs research Exact FDA submission Checked 2026-08-31
This field has not been curated yet.
Reported specificity
Research pending
Needs research Exact FDA submission Checked 2026-08-31
This field has not been curated yet.
No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.
Manufacturer dosimetry, image-performance, software, and system verification and validation · uMI Panorama 28 and 35 PET/CT systems; the 510(k) summary does not report a patient cohort
exact submission · Tested version: uMI Panorama 28 and 35 configuration cleared in K223325 · Sponsor or vendor study
K223325
Regulatory non-clinical evidence; it does not establish comparative clinical outcomes or local-site performance.
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-0225-2026 affects uMI Panorama 35 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 product version 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.
Exact uMI Panorama 35 model and native submission match. The recall is limited to affected model 35 units and describes a mechanical or accessory-use issue, not an AI-algorithm defect.
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
19Fields reviewed
7Source classes checked
8Unreviewed PubMed leads
0Unreviewed trial leads
0Unreviewed FDA recall leads
Recovered from the prior exact-submission extraction and normalized under the current provenance rules. The exact FDA summary, exact-identifier recall candidate, and current product-family page were manually reviewed. Clinical outcomes, local configuration, security, training, pricing, and reimbursement remain separate verification tasks. Automated exact-name discovery found 8 PubMed and 0 ClinicalTrials.gov candidate records. Candidates require human product and version matching; zero candidates is not evidence that no studies exist. 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 remain unpublished until a human confirms the exact product and tested version.
Source classes: fda ai list, fda decision summary, fda device recall, vendor product page, pubmed, clinical trials, openfda device recall
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