# K102435: Beyondimage Workstation

- Pathway: 510(k) (Traditional)
- Applicant: Neusoft Medical Systems Co., Ltd.
- Decided: Oct 15, 2010 after 50 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: 6 generations back to K010259 (2001). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092235: Beyondimage Workstation, Neusoft Medical Systems Co., Ltd. (2009) Summary page 2.
- K060505: Voxar 3D Enterprise, Model 6.1, Barcoview Mis Edinburgh (2006) Summary page 2.

## Indications for use
Beyondlmage Workstation is a software application that is used for viewing medical images. Beyondlmage Workstation receives digital images and data from various sources (including but not limited to CT, MR, US, RF units, computed and digital radiographic devices). Images are stored, communicated, processed and displayed on the local disc of a workstation and/or across computer networks at distributed locations. Taking that users may perform when viewing images include, but are not limited to adjustment of window width and center; image stacking; annotation and measurement of regions of interest; and inversion, rotation, and flips of images, it also provides standard Multi-Planar Reconstruction (MPR) views, Curved-Planar Reconstruction (CPR) views and 3D views of Volume Rendering for digital images from CT, MR, and PET unit. In addition, using Beyondlmage Workstation, users can edit and print report. Beyondlmage Workstation cannot display and process mammograms. Typical users of Beyondlmage Workstation are trained medical professionals, including but not limited to radiologists, clinicians, technologists, and others.

Source page: https://510kreport.com/device/K102435
Methodology: https://510kreport.com/methodology