# K963345: Advantage Windows Tissue Volume Option

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems
- Decided: Oct 18, 1996 after 53 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- 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 K913770 (1991). 1 ancestor in all.
472 later devices descend from it; 3 cite it directly.
1 of 474 devices in its family (counting itself) has 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.

## Most influential descendants
- K013381: Advanced Lung Analysis-1 (2001), 470 descendants of its own
- K022013: Lungcare CT Software Package (2002), 379 descendants of its own
- K033374: Lungcare CT Software Package with Extended Functionality (2003), 295 descendants of its own
- K063762: Syngo Circulation Software Package with Extended Functionality (2007), 263 descendants of its own
- K041484: Undecided (2004), 222 descendants of its own

## Indications for use
Advantage Windows Tisue Volume Option is intended to calculate the volume of any three dimensional structure from a set of CT images. The images are displayed and measured on the CT/MR Advantage Windows Diagnostic Workstation (K913770). The Tissue Volume Option will automate manual measurements and estimates that are currently made regarding the measure of volume of anatomy and pathology imaged with computed tomography.

Source page: https://510kreport.com/device/K963345
Methodology: https://510kreport.com/methodology