Authorized 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. K241585 adds reconstruction, respiratory-motion, CT-less attenuation-correction, quantitative-normalization, quality-control, and AI-expanded-field-of-view functions.
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: 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. K241585 adds reconstruction, respiratory-motion, CT-less attenuation-correction, quantitative-normalization, quality-control, and AI-expanded-field-of-view functions.
Overview status: Source-reviewed overview
What does this software do?Authorized 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. K241585 adds reconstruction, respiratory-motion, CT-less attenuation-correction, quantitative-normalization, quality-control, and AI-expanded-field-of-view functions.
Which images or clinical context are in scope?Modality: PET/SPECT/Nuclear Medicine Anatomy or clinical context: Multi-region Input: PET and CT images. The reconstructed PET AC images will be registered to user-selected CT images, and Retrospective Respiratory-gated Scan utilizes respiratory signal to visualize respiratory motion during scan.
Who uses it?Intended users: Qualified healthcare professionals.
What does the software produce?Output: Quantitative distribution information of PET radiopharmaceuticals within the patient body; diagnostic tomographic anatomical information and photon attenuation information from CT; accurate registration and fusion of PET and CT images; PET AC images generated without CT images and registered to user-selected CT images; phase-based or amplitude-based respiratory-gated reconstructions; accurate SUV normalization; and an automatic QC solution for the PET system.
What is its most important limitation?Key limitation: This system is intended to be operated by qualified healthcare professionals. This CT system can be used for low dose CT lung cancer screening for the early detection of lung nodules that may represent cancer. The screening must be performed within the established inclusion criteria of programs / protocols that have been approved and published by either a governmental body or professional medical society.
Clinical takeaway
Clinical role: 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. K241585 adds reconstruction, respiratory-motion, CT-less attenuation-correction, quantitative-normalization, quality-control, and AI-expanded-field-of-view functions.
Evidence takeaway
Evidence from the reviewed source record: Manufacturer-sponsored bench, algorithm, and image review supported the added software functions. The most detailed clinical evaluation was a 13-patient AIEFOV study with a separate test set and two blinded expert readers; it establishes feature-level image performance, not improved clinical 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
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. K241585 adds reconstruction, respiratory-motion, CT-less attenuation-correction, quantitative-normalization, quality-control, and AI-expanded-field-of-view functions.
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.
PET and CT images. The reconstructed PET AC images will be registered to user-selected CT images, and Retrospective Respiratory-gated Scan utilizes respiratory signal to visualize respiratory motion during scan.
FDA source
Exact FDA submission
Checked 2026-09-19
These are the packet's stated PET/CT, user-selected CT, and respiratory-signal inputs; PET coincidence and CT transmission data are not stated in the packet.
Quantitative distribution information of PET radiopharmaceuticals within the patient body; diagnostic tomographic anatomical information and photon attenuation information from CT; accurate registration and fusion of PET and CT images; PET AC images generated without CT images and registered to user-selected CT images; phase-based or amplitude-based respiratory-gated reconstructions; accurate SUV normalization; and an automatic QC solution for the PET system.
FDA source
Exact FDA submission
Checked 2026-09-19
The packet directly states these PET, CT, fusion, CT-less AC, respiratory-gated, SUV-normalization, and automatic-QC outputs; it does not state the dossier's contemporaneous-CT wording.
This system is intended to be operated by qualified healthcare professionals. This CT system can be used for low dose CT lung cancer screening for the early detection of lung nodules that may represent cancer. The screening must be performed within the established inclusion criteria of programs / protocols that have been approved and published by either a governmental body or professional medical society.
FDA source
Exact FDA submission
Checked 2026-09-19
The replacement preserves the packet's operator and screening boundaries and removes the dossier's unsupported generalization about clinical outcomes and the AIEFOV population.
The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.
Use these fields to structure a vendor demo, security review, and implementation estimate.
Integration
The scanner control and reconstruction environment provides patient and data management, networking, image display and post-processing, and DICOM-standard image exchange.
FDA source
Exact FDA submission
Checked 2026-09-02
Confirm DICOM services, PACS and RIS connectivity, CT selection and registration workflows, respiratory-signal interfaces, and quantitative-image preservation for the installed build.
On-premises uMI Panorama GS PET/CT scanner with a 760 mm bore, 148 cm PET axial field of view, 504 PET detector rings, integrated uCT ATLAS Astound CT subsystem, and table rated to 250 kg.
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.
Reconstruction and quantitative workflow
Added AIIR, HYPER Iterative, uExcel DPR, uKinetics, and uExcel Unity functions support image reconstruction, dynamic analysis, and SUV normalization.
exact submission · checked 2026-09-02
Confirm licensed options, supported radiotracers and protocols, reconstruction times, quantitative harmonization, and local quality-control tolerances.
CT-less attenuation correction can generate PET attenuation correction without a contemporaneous CT and register the result to a user-selected CT; AIEFOV uses deep learning to extend truncated CT anatomy for supported workflows.
exact submission · checked 2026-09-02
Define CT selection, registration review, fallback, artifact review, and quantitative acceptance procedures before clinical use.
United Imaging maintains a current uMI Panorama family page, but its claims may cover different axial-field-of-view configurations or software releases and do not substitute for the exact GS quotation and technical file.
product family · checked 2026-09-02
Map every quoted feature, version, interface, service level, and price to the installed 148 cm GS 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
Manufacturer-sponsored bench, algorithm, and image review supported the added software functions. The most detailed clinical evaluation was a 13-patient AIEFOV study with a separate test set and two blinded expert readers; it establishes feature-level image performance, not improved clinical outcomes.
No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.
K241585 added-function verification and clinical-image review
DesignManufacturer algorithm, bench, image-performance, and software verification and validation with sample clinical-image review by U.S. board-certified radiologists
PopulationuMI Panorama GS software functions including AIIR, HYPER Iterative, uExcel DPR, motion correction, AIEFOV, motion management, CT-less attenuation correction, retrospective respiratory gating, uExcel Unity, and uExcel iQC; the general clinical-image sample size was not reported
Scopeexact submission
Tested versionuMI Panorama GS software functions cleared in K241585
IndependenceSponsor or vendor study
K241585
The FDA summary reports diagnostic sufficiency for reviewed sample images but no clinical outcomes endpoint or independent sponsor.
DesignManufacturer-sponsored clinical image evaluation using a test set separated from training and blind review by two U.S. board-qualified clinical experts
Population9,303 images from 13 patients representing different CT truncation situations; the training set contained 506,476 manually quality-controlled images
Scopeexact submission
Tested versionAIEFOV on uMI Panorama GS cleared in K241585
Samplen=13
IndependenceSponsor or vendor study
K241585
Readers assessed artifacts, tissue homogeneity, and PET diagnostic confidence. FDA reports improved CT-value and SUV accuracy when anatomy exceeded the CT scan field of view and consistent results when it did not; numerical effect sizes were not reported.
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.
Exact FDA record reviewedStatus
2026-09-20Last searched
20Fields reviewed
10Source classes checked
8Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads
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. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 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 history6 sources - 3 history items
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 GS combines 148 cm axial-field-of-view PET with CT to provide quantitative radiopharmaceutical distribution, diagnostic anatomical and attenuation information, and...
uMI Panorama combines PET and CT to provide quantitative radiopharmaceutical distribution, diagnostic anatomical and attenuation information, and fused PET/CT images for qualified...