# K221932: Omni Legend

- Pathway: 510(k) (Traditional)
- Applicant: GE Healthcare
- Decided: Sep 2, 2022 after 63 days
- Product code: KPS (System, Tomography, Computed, Emission)
- Device class: 2
- Regulation: 21 CFR 892.1200
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K010641 (2001). 11 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211846: Discovery MI Gen2, Ge Medical Systems, LLC (2021) Summary page 5.

## Most influential descendants
- K241665: Omni Legend (2024), 0 descendants of its own
- K223212: Precision DL (2023), 0 descendants of its own

## Recalls of this device
- Dec 24, 2025 · Class II · Z-1112-2026: There is a potential intermittent issue on certain Omni Legend systems that can result in a streaking artifact in the PET clinical scan images. This streaking artifact is most easily identified in tra

## Indications for use
The GE Omni Legend is a PET/CT system for producing attenuation corrected PET images. It is intended to be used by qualified health care professionals for imaging the distribution and localization of any positron-emitting radiopharmaceutical in a patient, for the assessment of metabolic (molecular) and physiologic function in patients, with a wide range of sizes and extent of disease, of all ages. Omni Legend is intended to image the whole body, head, heart, brain, lung, breast, bone, the gastrointestinal and lymphatic systems, and other organs. The images produced by the system may be used by physicians to aid in radiotherapy treatment planning, therapy guidance and monitoring, and in interventional radiology procedures. The images may also be used for precise functional and anatomical mapping (localization, registration, and fusion). When used with radiopharmaceuticals approved by the regulatory authority in the country of use, the raw and image data is an aid in; detection, localization, evaluation, diagnosis, staging, restaging, monitoring, and/or follow up, of abnormalities, lesions, tumors, inflammation, infection, organ function, disorders, and/or disease, such as, but not limited to, those in oncology, cardiology, and neurology. Examples of which are: Cardiology: • Cardiovascular disease • Myocardial perfusion • Myocardial viability • Cardiac inflammation • Coronary artery disease Neurology: • Epilepsy • Dementia, such as Alzheimer’s disease, Lewy body dementia, Parkinson’s disease with dementia, and frontotemporal dementia • Movement disorders, such as Parkinson’s and Huntington’s disease • Tumors • Inflammation • Cerebrovascular disease such as acute stroke, chronic and acute ischemia • Traumatic Brain Injury (TBI) Oncology/Cancer: • Non-Small Cell Lung Cancer • Small Cell Lung Cancer • Breast Cancer • Prostate Cancer • Hodgkin disease • Non-Hodgkin lymphoma • Colorectal Cancer • Melanoma Omni Legend is also intended for stand-alone, diagnostic CT imaging in accordance with the stand-alone CT system’s cleared indications for use.

Source page: https://510kreport.com/device/K221932
Methodology: https://510kreport.com/methodology