Turn this list into an evaluation

Each entry is an FDA submission, not a distinct commercial offer. Inspect the exact record before comparing evidence, asking for a quote or planning an integration.

Prepare with a buyer guide:

Clinical guide links appear when this list contains a current reviewed example. They do not classify or endorse the other entries. All buyer guides · Compare exact records · Documented families

FDA-cleared K243863

Opulus™ Lymphoma Precision

Roche Molecular Systems, Inc.

Authorized 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.

Modality
PET/SPECT/Nuclear Medicine
Anatomy
Whole-body FDG-PET/CT
Decision
2025-05-30