# K211846: Discovery MI Gen2

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems, LLC
- Decided: Aug 20, 2021 after 66 days
- Product code: KPS (System, Tomography, Computed, Emission)
- Device class: 2
- Regulation: 21 CFR 892.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K010641 (2001). 10 ancestors in all.
3 later devices descend from it; 1 cites 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)
- K161574: Discovery MI, Ge Medical Systems, LLC (2016) Summary page 6.

## Most influential descendants
- K221932: Omni Legend (2022), 2 descendants of its own
- K241665: Omni Legend (2024), 0 descendants of its own
- K223212: Precision DL (2023), 0 descendants of its own

## Indications for use
The GE Discovery MI Gen2 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. Discovery MI Gen2 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’s disease » Non-Hodgkin’s lymphoma * Colorectal Cancer * Melanoma Discovery MI Gen2 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/K211846
Methodology: https://510kreport.com/methodology