# K253844: AnyScan 3.0 NM Scanner Family

- Pathway: 510(k) (Traditional)
- Applicant: Mediso Medical Imaging Systems, Ltd.
- Decided: Dec 30, 2025 after 28 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: 16 generations back to K002715 (2000). 46 ancestors in all.
No later device cites it as a predicate yet.
1 of 47 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200474: Symbia 6.7, Siemens Medical Solutions USA, Inc. (2020) Summary page 6.
- K193178: Biograph Horizon, Siemens Medical Solution USA, Inc. (2020) Summary page 6.

## Indications for use
The AnyScan 3.0 NM Scanner Family is intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning or additional uses. The SPECT subsystem is intended to provide projection and cross-sectional images through computer reconstruction of the data, representing radioisotope distribution in the patient body or in a specific organ using planar and tomographic scanning modes for isotopes with energies up to 588 keV. CT component is intended to provide cross sectional images of the body by computer reconstruction of xray transmission data providing anatomical information. The PET component is intended to provide cross- sectional images representing the distribution of tomographic scanning modes. The SPECT and CT components used together acquire SPECT/CT images. The SPECT images can be corrected for attenuation with the CT images, and can be combined (image registration) to merge the patient's physiological (SPECT) and anatomical (CT) images. The PET and CT components used together acquire PET/CT images. The PET images can be corrected for attenuation with the CT images, and can be combined (image registration) to merge the patient's physiological (PET) and anatomical (CT) images. The system maintains independent functionality of the SPECT, CT and PET components, allowing for single modality SPECT, CT and/ or PET diagnostic imaging. Software: The Nucline software is an acquisition, display and analysis package intended to aid the clinician to extract diagnostic information supported by image assessment tools, image enhancement features and image quantification of pathologies in images produced from SPECT, CT, PET and other imaging modalities. This CT system can be used for low dose lung cancer screening in high risk populations.*

Source page: https://510kreport.com/device/K253844
Methodology: https://510kreport.com/methodology