# K960265: Advantage Windows with Functool Option

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems
- Decided: Jul 3, 1996 after 167 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- 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 K913475 (1991). 2 ancestors in all.
180 later devices descend from it; 13 cite it directly.
2 of 183 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K913770: Advantage V.S. CT/MR Rad Diagnostic Workstation, General Electric Co. (1991) Summary page 1.
- K913475: Magnetic Resonance Diagnostic Device, GE Medical Systems (1991) Summary page 1.

## Most influential descendants
- K971965: Philips Easyvision (1998), 74 descendants of its own
- K022292: Impax Diagnostic Display Station,Impax Clinical Review Station,Impax for Cardiology Clinical Review Satation,Impax Ortho (2002), 48 descendants of its own
- K110573: Ready View (2011), 38 descendants of its own
- K061429: Dynamic Mri Software Option for C-Scan, E-Scan XQ and E-Scan Opera (2006), 32 descendants of its own
- K063505: Visualase Envision Software System (2006), 27 descendants of its own

## Recalls of this device
- Aug 18, 2011 · Not classified · Z-3282-2011: GE Healthcare has become aware that image orientation of reference series displayed in Functool Diffusion Tensor/FiberTrak protocol on Advantage Workstation may not match with the orientation annotati

## Indications for use
The FuncTool option to the Advantages Windows workstation is a software module that provides supplemental information to those images extracted from CT and MR temporal datasets.

Source page: https://510kreport.com/device/K960265
Methodology: https://510kreport.com/methodology