# K935694: Sienet Diagnostic Reporting Console VA02 Upgrade

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Mar 7, 1994 after 98 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K033831: Sienet Cosmos (2003), 6 descendants of its own
- K042832: Sienet Cosmos (Version V15A) (2004), 5 descendants of its own
- K052461: Syngo Imaging Version V20A (2005), 2 descendants of its own
- K070755: Interworks (2007), 1 descendant of its own
- K141556: Avreo Interworks System (2014), 0 descendants of its own

## Recalls of this device
- Sep 5, 2006 · Not classified · Z-0072-2007: Potential issue with annotation function. Annotations, shown as overlays, may change font size when the image is saved. Text may appear shifted, or lines appear thicker, and their position may not be 
- Sep 5, 2006 · Not classified · Z-0071-2007: Potential issue with annotation function. Annotations, shown as overlays, may change font size when the image is saved. Text may appear shifted, or lines appear thicker, and their position may not be 
- Apr 1, 2004 · Not classified · Z-1095-04: Recalling firm became aware of a potential problem through the submission of a product complaint to the firm reporting the Image Navigator feature in the MagicView 300 VA42A or VA42B software are not 
- Jul 3, 2003 · Not classified · Z-0840-03: Potential error can occur with the 3D post processing options MPR, MIP, and VRT.

Source page: https://510kreport.com/device/K935694
Methodology: https://510kreport.com/methodology