uMI Panorama GS combines 148 cm axial-field-of-view PET with 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 GS combines 148 cm axial-field-of-view PET with 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 acquisition, reconstruction, display, post-processing, quantitative PET review, PET/CT registration and fusion, CT dose display, networking, and filming within an integrated scanner environment.
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. The FDA summary reports non-clinical image-performance testing but no clinical outcomes study or patient sample size.
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
K231572
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 environment provides patient and data management, networking, display, post-processing, and DICOM exchange conforming to NEMA PS 3.1 through PS 3.20 (2022d).
FDA source Exact FDA submission Checked 2026-09-02
Confirm supported DICOM services, object types, modality worklist behavior, PACS and RIS connectivity, and interface conformance for the installed software build.
On-premises uMI Panorama GS PET/CT scanner with separate PET and CT gantries, a 760 mm bore, 148 cm PET axial field of view, integrated table rated to 250 kg, power cabinet, control and reconstruction environment, chiller, and vital-signal module.
FDA source Exact FDA submission Checked 2026-09-02
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/CT system with 504 PET detector rings, 148 cm PET axial field of view, a 760 mm bore, uCT ATLAS Astound CT subsystem, and a 250 kg maximum table load.
The cleared system includes PET and CT gantries, patient table, power cabinet, control and reconstruction environment, chiller, and vital-signal module.
exact submission · checked 2026-09-02
Confirm site-preparation, service, uptime, preventive-maintenance, and replacement-part commitments during contracting.
Provides DICOM-standard exchange plus acquisition, reconstruction, patient and data management, dose display, networking, image display, post-processing, and filming functions.
United Imaging maintains a current uMI Panorama family page, but that page primarily describes shorter axial-field-of-view configurations and should not be treated as the exact uMI Panorama GS specification.
product family · checked 2026-09-02
Obtain a current, configuration-specific quotation and technical data package for the 148 cm GS system.
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 image-performance, system, and software testing. No independent clinical outcomes study or patient sample size 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 image-performance, system, and software verification and validation · uMI Panorama GS PET/CT system with 148 cm PET axial field of view; the 510(k) summary does not report a patient cohort
exact submission · Tested version: uMI Panorama GS configuration cleared in K231572 · Sponsor or vendor study
K231572
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
Not established in reviewed sources
Reviewed sources checked Exact FDA submission Checked 2026-09-04
No native submission-identifier match was found in the checked openFDA radiology recall snapshot. Product-name, manufacturer, and adverse-event searches remain necessary; this does not establish that no recall or safety report exists.
Buyer worksheet
Open questions to take to the vendor
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.
Verify recalls and postmarket safety signals: No native submission-identifier match was found in the checked openFDA radiology recall snapshot. Product-name, manufacturer, and adverse-event searches remain necessary; this does not establish that no recall or safety report exists.
This audit distinguishes completed source review from fields that have not yet been researched.
Human reviewedStatus
2026-09-04Last searched
18Fields 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. No matching recall was accepted. Clinical outcomes, installed interfaces, cybersecurity, staffing, training, service terms, price, total cost, 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. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 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
uMI Panorama combines PET and CT to provide quantitative radiopharmaceutical distribution, diagnostic anatomical and attenuation information, and fused PET/CT images for qualified...
uMI Panorama combines PET and CT to provide quantitative radiopharmaceutical distribution, diagnostic anatomical and attenuation information, and fused PET/CT images for qualified...
syngo.via MI Workflows, Scenium, and syngo MBF provide PET, SPECT, nuclear-medicine, CT, and MR viewing, manipulation, quantification, longitudinal comparison, and analysis for...