# K160334: Advanced Medical Imaging Software Suite (KSWVWR)

- Pathway: 510(k) (Traditional)
- Applicant: Keosys Sas
- Decided: Jun 21, 2016 after 134 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K913770 (1991). 206 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 209 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113620: Myrian 1.11, Intrasense (2012) Summary page 4.
- K103576: Mim 5.2 (Brachy), Mim Software, Inc. (2011) Summary page 4.
- K101228: Mirada XD, Mirada Medical, Ltd. (2010) Summary page 4.
- K140269: Hermes Medical Imaging Suite V5.4, Hermes Medical Solutions AB (2014) Summary page 4.
- K102000: Imagys, Keosys Sas (2010) Summary page 4.

## Most influential descendants
- K211655: aPROMISE (2021), 1 descendant of its own
- K220590: aPROMISE X (2022), 0 descendants of its own

## Indications for use
Keosys Medical Imaging Suite (KSWVWR) is intended to be used by trained medical professionals included, but not limited to, radiologists, nuclear medicine physicians and physicists. Keosys Medical Imaging Suite is a software application intended to aid in diagnostic and evaluation of medical image data. Although this device allows the visualization of mammography images, it is not intended as a tool for primary diagnosis in mammography. Keosys Medical Imaging Suite can be used for display, process, temporarily store, print and also create and print reports from 2D and 3D multimodal DICOM medical image data. The imaging data can be Computed Tomography (CT), Magnetic Resonance (MR), Radiography X (CR, DX, XA, XRF, MG), Nuclear Medecine (NM) including planar imaging (Static, Whole body, Dynamic, Gated) and tomographic imaging (SPECT, Gated SPECT), Positon Emission Tomography (PT), Ultrasound (US). Keosys Medical Imaging suite provides tools like rulers, markers or region of interests (e.g. it can be used in an oncology clinical workflow for tumor burden assessment or therapeutic response evaluation). It is the user responsibility to check that the ambient luminosity conditions, the images compression ratio and the interpretation monitor specifications are consistent with a clinical diagnostic use of the data.

Source page: https://510kreport.com/device/K160334
Methodology: https://510kreport.com/methodology