# K012097: Vortex

- Pathway: 510(k) (Traditional)
- Applicant: Ultravisual Medical Systems
- Decided: Jul 12, 2001 after 7 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: 3 generations back to K954678 (1996). 6 ancestors in all.
18 later devices descend from it; 4 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992654: Plug 'N View 3D, Version 1.0, Voxar Limited (1999) Summary page 2.
- K970064: Amicas Web/Intranet Image Server, Autocyt Group, Inc. (1997) Summary page 2.

## Most influential descendants
- K061421: Erad Pacs (2006), 14 descendants of its own
- K120995: Erad Pacs/Erad Ris/Pacs/Erad Epvlite Viewer Software Product (2012), 7 descendants of its own
- K152977: DG Pacs (2016), 4 descendants of its own
- K132799: Clariso Pacs (2013), 4 descendants of its own
- K151957: BOX DICOM Viewer (2015), 3 descendants of its own

## Indications for use
The system is designed to provide image storage, display, and workflow integration capabilities for healthcare enterprises. The image display architecture provides workgroup diagnostic viewing capabilities for radiologists as well as image reviewing functionality for referring physicians and other clinicians. In addition to traditional 2D image viewing functionality, the image display system provides advanced 3D features including volume rendering and multi-planar reconstruction designed to function in web-enabled viewers over both local and wide area networks. Intended users of the image distribution system include radiologists, referring physicians, tertiary care physicians, medical technologists, and information technology professionals.

Source page: https://510kreport.com/device/K012097
Methodology: https://510kreport.com/methodology