Opulus Lymphoma Precision segments and visualizes lesions and measures total metabolic tumor volume in whole-body FDG-PET/CT for patients already diagnosed with FDG-avid lymphoma; trained physicians can accept/reject annotated output, but radiologist review makes the final interpretation and the device is not a screening/diagnostic substitute.
Evidence status: each field states its source quality, applicability, and review date. Research pending, information not established, and vendor documentation pending remain distinct 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
Opulus Lymphoma Precision segments and visualizes lesions and measures total metabolic tumor volume in whole-body FDG-PET/CT for patients already diagnosed with FDG-avid lymphoma; trained physicians can accept/reject annotated output, but radiologist review makes the final interpretation and the device is not a screening/diagnostic substitute.
Whole-body FDG-PET/CT in standard DICOM format, consisting of PET with associated attenuation-correction CT, from patients with pathologically diagnosed FDG-avid lymphoma.
Localization and segmentation of FDG-avid lesions, overlay visualization, segmentation masks, a total metabolic tumor volume measurement, and a report/image overlay; the physician may accept or reject the algorithm output but cannot modify it.
The device is assistive for already diagnosed FDG-avid lymphoma, is not a screening tool or diagnostic substitute, and requires trained physician review and final interpretation.
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 submission describes standard DICOM PET/CT input, report generation, and image/segmentation-mask overlays; current PACS/workstation routing and deployment architecture were not established.
The reviewed sources establish DICOM image-processing function and commercial distribution, but not a current hosting model or regional data flow.
Security and privacy
Vendor documentation pending
Vendor confirmation
Exact FDA submission
Checked 2026-09-07
No scoped current security, data-flow, access-control, retention, or incident-response documentation was established.
Training and support
Vendor documentation pending
Vendor confirmation
Exact FDA submission
Checked 2026-09-07
Current onboarding, competency, and support commitments were not established.
Monitoring and change control
Vendor documentation pending
Vendor confirmation
Exact FDA submission
Checked 2026-09-07
Local acceptance testing, production monitoring, update control, and drift review were not established.
DICOM PET/CT image-processing workflow
AccessGUDID lists Opulus Lymphoma Precision as a DICOM image-processing software device and records it as in commercial distribution; the current hosting model and local integration are not documented there.
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
Test-set validation used 182 unique patients across multiple geographies and PET/CT vendors; the FDA compares cube-root-transformed total metabolic tumor volume differences in centimeters, using a 2.5 cm threshold on that transformed scale, against a reference generated by nine radiologists and nuclear medicine physicians.
Opulus Lymphoma Precision TMTV and segmentation validation
DesignRetrospective test-set validation against pooled physician reference
Population182 unique patients from multiple geographies and GE, Siemens, and Philips PET/CT systems
Scopeexact submission
Tested versionOpulus Lymphoma Precision submitted in K243863; build not stated
Samplen=182
IndependenceIndependence not established
K243863
The FDA describes the test data as independent from training data; reference pool comprised nine radiologists and nuclear medicine physicians. Independence of investigators or sponsorship was not established. TMTV differences are on the cube-root-transformed scale, with the 2.5 cm group threshold on that scale.
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 2026-09-07
No public amount, range, currency, geography, or contract term was established.
Reimbursement and coding
Research pending
Needs research
Exact FDA submission
Checked 2026-09-07
No payer or CMS policy review was performed in this worker cohort.
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 deployment and data flow: The reviewed sources establish DICOM image-processing function and commercial distribution, but not a current hosting model or regional data flow.
Verify security and privacy controls: No scoped current security, data-flow, access-control, retention, or incident-response documentation was established.
Verify training: Current onboarding, competency, and support commitments were not established.
Verify pricing and total cost: No public amount, range, currency, geography, or contract term was established.
Verify reimbursement and coding relevance: No payer or CMS policy review was performed in this worker cohort.
Verify local validation and lifecycle monitoring: Local acceptance testing, production monitoring, update control, and drift review were not established.
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
2026-09-07Last searched
24Fields reviewed
10Source classes checked
0Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads
No stored PubMed or ClinicalTrials.gov candidate identifiers for this submission in the 2026-09-01 snapshot; exact-submission recall candidate review was also zero. This metadata screen is not a full paper review. The current discovery snapshot contains 0 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, acr ai central product, government device registry, literature index, trial registry, fda device recall, 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 history8 sources - 2 history items
syngo.via MI Workflows, Scenium, and syngo MBF provide PET, SPECT, nuclear-medicine, CT, and MR viewing, manipulation, quantification, longitudinal comparison, and analysis for...
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...