# K972399: Advantage Windows Volume Rendering Option

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems, Inc.
- Decided: Sep 23, 1997 after 89 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K871859 (1987). 3 ancestors in all.
516 later devices descend from it; 2 cite it directly.
1 of 520 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K923077: Advantage Windows 3D Option and Dentascan Option, GE Medical Systems (1993) Summary page 1.
- K954355: Advantage Windows 3D with Navigator Option, General Electric Co. (1995) Summary page 1.
- K871859: CT9800 Quick 3D #B7919DA, General Electric Co. (1987) Summary page 1.

## Most influential descendants
- K041521: Volume Viewer Plus (2004), 469 descendants of its own
- K061696: Iqqa-Liver Software (2006), 217 descendants of its own
- K063324: Pet Vcar (2007), 204 descendants of its own
- K091373: Syngo Trued (2009), 200 descendants of its own
- K071310: Syngo CT Oncology Software Package (2007), 195 descendants of its own

## Recalls of this device
- May 25, 2012 · Class II · Z-0901-2013: Incorrect views and measurements possible. GE Healthcare became aware of multiple potential safety issues involving the Advantage workstation, Volume Viewer Plus and Volume Analysis.

## Indications for use
The Advantage Windows Volume Rendering Option is intended to provide volume visualization of three dimensional structures imaged with computed tomography (CT), or magnetic resonance (MR). It reconstructs and displays translucent 3D models to be used for diagnosis confidence or planning surgical treatment. The images are reconstructed and displayed on the CT/MR Advantage Windows Diagnostic Workstation (K913770).

Source page: https://510kreport.com/device/K972399
Methodology: https://510kreport.com/methodology