# K993792: Smart Vessel Analysis (Smart VA) Option

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems, Inc.
- Decided: Nov 24, 1999 after 15 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K926258 (1993). 2 ancestors in all.
60 later devices descend from it; 3 cite it directly.
0 of 63 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954355: Advantage Windows 3D with Navigator Option, General Electric Co. (1995) Summary page 1.
- K926258: DLX, GE Medical Systems (1993) Summary page 1.

## Most influential descendants
- K060779: Advance Vessel Analysis II (2006), 55 descendants of its own
- K061370: Cardiq Fusion (2006), 51 descendants of its own
- K033361: Viatronix V3D Vascular, Revision 1.0 (2003), 22 descendants of its own
- K073156: Qplaque MR (2008), 21 descendants of its own
- K103465: Synapse 3D Cardiac Tools (2011), 20 descendants of its own

## Indications for use
Smart Vessel Analysis (SmartVA) is a software post-processing option for the Advantage Workstation (AW) platform which can be used in the analysis of 3D angiography data. It provides a number of display, measurement and batch filming/archive features and will aid physicians in studying user-selected vessels for stenosis analysis, pre/post stent planning and directional vessel tortuosity visualization.

Source page: https://510kreport.com/device/K993792
Methodology: https://510kreport.com/methodology