Opulus Lymphoma Precision

K243863

Roche Molecular Systems, Inc. · cleared 2025-05-30 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.4)

“Opulus™ Lymphoma Precision is a software device that uses a machine learning-based algorithm to automate segmentation and visualization of lesions along with automation of measurement of total metabolic tumor volume within whole-body FDG-PET/CT scans of patients with FDG-avid lymphomas.”

AlgorithmArtificial Intelligence Machine Learning (AI/ML) Algorithm

source quote (p.7)

“Artificial Intelligence Machine Learning (AI/ML) Algorithm”

Adaptive (vs locked)No

source quote (p.6)

“The user does not have the ability to modify the device output.”

PCCPFDA source did not state this

Cybersecurity addressedFDA source did not state this

Validation studies (1)

Retrospective clinical

n=182 patients

endpoints: agreement of TMTV quantitative estimates between aTMTV and manual (mTMTV); accuracy in lesion segmentation by comparing aTMTV-generated contours and ground truth

standards: IEC 62304:2006/AC:2015 - Medical device software – Software life cycle processes

Reported performance (1 observation)

diceas written: “Mean DSC score”0.7CI 95% CI, 0.66, 0.73

source quote (p.9)

“The mean DSC score was 0.70 (95% CI, 0.66, 0.73).”

Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.

Predicate network

Postmarket — what happened after clearance

recalls in product code, 24mo

MAUDE reports in code, 12mo

—

vs code's own 3-yr baseline

drift signals on this device

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).