# K102000: Imagys

- Pathway: 510(k) (Traditional)
- Applicant: Keosys Sas
- Decided: Oct 12, 2010 after 89 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: 9 generations back to K954874 (1996). 44 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042313: Integradweb MPR/Mip, Dynamic Imaging, Inc. (2004) Summary page 1.
- K020995: Efilm Workstation with Modules, Efilm Medical, Inc. (2002) Summary page 1.
- K070606: Visio+CD Viewer# KPSCDVE01, Keosys Sas (2007) Summary page 1.

## Most influential descendants
- K160334: Advanced Medical Imaging Software Suite (KSWVWR) (2016), 2 descendants of its own
- K211655: aPROMISE (2021), 1 descendant of its own
- K220590: aPROMISE X (2022), 0 descendants of its own

## Indications for use
Imagys (KSNRMAVWRxx, KSNERDxx) is a medical solution for the upload, the secure transfer, the management, the viewing, the reviewing, the printing, the storage and archiving of imaging data, and the related documentations, acquired from a variety of imaging devices. Imagys can also support the management of the imaging parts of a clinical trial workflow including the following steps : quality control, data processing and audit trails. Imagys runs on any standard PC and servers compliant with the Imagys specifications. Typical end users are trained medical professionals and clinical trial actors. The imaging data can be CT (Computed Tomography), MR (Magnetic Resonance), CR (Computed Radiography), NM (Nuclear Medecine), PET (Positon Emission Tomography), SC (Secondary Capture), US (Ultrasound), XA (Angiographic), video and more DICOM, or others imaging standards, data accepted by the Imagys solution. 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. This device is not indicated for mammography use. Lossy compressed mammography-images and digitized film screen images must not be used for primary image interpretations. Mammography images may only be interpreted using an FDA approved monitor that offers at least 5 mega pixel resolution and meets other technical specifications approved by the FDA.

Source page: https://510kreport.com/device/K102000
Methodology: https://510kreport.com/methodology