FDA-cleared profile
Shanghai United Imaging Healthcare Co., Ltd.
Authorized purpose: uMI Panorama combines PET and CT to provide quantitative radiopharmaceutical distribution, diagnostic anatomical and attenuation information, and fused PET/CT images for qualified healthcare professionals supporting detection, localization, diagnosis, staging, restaging, treatment planning, and treatment-response evaluation across oncology, cardiology, neurology, and other disorders; its CT subsystem can also perform standalone diagnostic imaging and protocol-governed low-dose lung cancer screening.
Product overview
Authorized purpose: uMI Panorama combines PET and CT to provide quantitative radiopharmaceutical distribution, diagnostic anatomical and attenuation information, and fused PET/CT images for qualified healthcare professionals supporting detection, localization, diagnosis, staging, restaging, treatment planning, and treatment-response evaluation across oncology, cardiology, neurology, and other disorders; its CT subsystem can also perform standalone diagnostic imaging and protocol-governed low-dose lung cancer screening.
Overview status: Source-reviewed overview
Clinical role: uMI Panorama combines PET and CT to provide quantitative radiopharmaceutical distribution, diagnostic anatomical and attenuation information, and fused PET/CT images for qualified healthcare professionals supporting detection, localization, diagnosis, staging, restaging, treatment planning, and treatment-response evaluation across oncology, cardiology, neurology, and other disorders; its CT subsystem can also perform standalone diagnostic imaging and protocol-governed low-dose lung cancer screening.
Evidence from the reviewed source record: 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.
Clinical details
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
Clinical-use display mirrors the exact FDA-supported purpose reconciled from the decision-summary packet.
The exact indications for use state that the system is intended to be operated by qualified healthcare professionals.
The exact indications for use directly describe the PET radiopharmaceutical information and CT information provided by the two modalities.
The exact packet supports the image, registration/fusion, and uExcel Focus performance wording without adding unsupported review or output-object claims.
The exact indications for use state the qualified-user boundary and the required approval/publication boundary for low-dose CT lung cancer screening.
Regulatory identity
The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.
The exact indications for use state that the uMI Panorama combines the two imaging modalities PET and CT. Controlled directory display reconciled from exact FDA wording: PET and CT -> PET/SPECT/Nuclear Medicine.
Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.
Implementation
Use these fields to structure a vendor demo, security review, and implementation estimate.
Confirm supported DICOM services, object types, PACS and RIS connectivity, worklist behavior, and interface versions for the installed configuration.
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, onboarding, competency, and support commitments are commercial implementation details that require current vendor documentation.
Local acceptance testing, production monitoring, drift review, update control, and incident escalation require a current vendor and site-specific governance plan.
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 2026-09-02Confirm ordered detector coverage, table accessories, room requirements, power, cooling, shielding, and service clearances.
Includes uExcel Iterative, neural-network-based uExcel DPR, and uExcel Focus or HYPER Focus respiratory-motion correction for supported PET workflows.
exact submission · checked 2026-09-02Confirm licensed options, radiotracer and protocol support, processing times, and local quality-control procedures.
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 2026-09-02Validate 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 2026-09-02Current family-page claims may span configurations or software releases; map them to the quoted and installed system before procurement or validation.
Evidence
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.
This field has not been curated yet.
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.
K223325
Regulatory non-clinical evidence; it does not establish comparative clinical outcomes or local-site performance.
Costs and setup
These are common procurement questions; unknown values remain visible until a source supports them.
FDA submission materials do not establish current commercial pricing. Request the pricing unit, term, minimum commitment, implementation fees, and included support from the vendor.
Determine whether any product-specific CPT/HCPCS pathway exists and separate it from billing for the underlying imaging service.
Safety and lifecycle
Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.
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.
Open, Classified
2025-10-21Exact 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.
Buyer worksheet
Research record
This audit distinguishes completed source review from fields that have not yet been researched.
The refreshed discovery snapshot contains 8 PubMed and 0 ClinicalTrials.gov candidate records. 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 8 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
Open the ledger for source dates, scope, and research-record updates.
Scope: purpose, anatomy, modality, intendedUsers, input, output, limitations, evidenceSummary, clinicalUse
Scope: regulatoryIdentity, modalityContext
Scope: postmarketSafety, affectedProduct, recallStatus, correctiveAction
Scope: evidenceDiscovery
Scope: evidenceDiscovery, studyStatus
Scope: recallDiscovery, nativeSubmissionMatching
Scope: productFamily, implementationCapabilities, currentCommercialContext
Regulatory record
510(k)
Research record
human reviewed
Editorial review
Source-reviewed editorial overlay
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