# K243863: Opulus™ Lymphoma Precision

- Pathway: 510(k) (Traditional)
- Applicant: Roche Molecular Systems, Inc.
- Decided: May 30, 2025 after 164 days
- Product code: QIH (Automated Radiological Image Processing Software)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K061855 (2006). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221738: NS-HGlio, Neosoma, Inc. (2022) Summary page 5.

## Indications for use
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. Opulus™ Lymphoma Precision is used to assist trained interpreting physicians with visualization of suspected lesions and calculation of total volume of all lesions in a body. This information can be used in addition to the standard of care image interpretation of FDG-PET/CT scans. Opulus™ Lymphoma Precision annotated images can be reviewed by an appropriately trained physician. The algorithm is assistive, and requires a radiologist review, who will make the final decision on FDG-PET/ CT image interpretation.

Source page: https://510kreport.com/device/K243863
Methodology: https://510kreport.com/methodology