# K241266: Imaging system of positron emission and X-ray computed tomography (DigitMI 930)

- Pathway: 510(k) (Traditional)
- Applicant: Raysolution Healthcare Co., Ltd.
- Decided: Jan 27, 2025 after 266 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.
No later device cites it as a predicate yet.
0 of 11 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 8.

## Indications for use
The Imaging system of positron emission and X-ray computed tomography 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. Imaging system of positron emission and X-ray computed tomography 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 Imaging system of positron emission and X-ray computed tomography 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/K241266
Methodology: https://510kreport.com/methodology