# K041521: Volume Viewer Plus

- Pathway: 510(k) (Traditional)
- Applicant: General Electric Medical Systems
- Decided: Jun 22, 2004 after 14 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K871859 (1987). 5 ancestors in all.
469 later devices descend from it; 17 cite it directly.
1 of 475 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972399: Advantage Windows Volume Rendering Option, Ge Medical Systems, Inc. (1997) Summary page 1.
- K012313: CT Colonography/NAVIGATOR2, Ge Medical Systems, Inc. (2001) Summary page 1.

## Most influential descendants
- 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
- K083524: Syngo Dual Energy with Extended Funationally (2009), 117 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.
- May 1, 2008 · Not classified · Z-2312-2008: GE Healthcare has recently became aware of a possible mismatch between the label of the tracked vessel and the underlying image associated with the cardio- vascular applications of the Advantage works

## Indications for use
Volume Viewer Plus is a medical diagnostic software that allows the processing, review, analysis and communication of 3D reconstructed images and their relationship to originally acquired images from CT, MR, X-Ray Angio and PET Scanning devices. The combination of acquired images, reconstructed images, annotations and measurements performed by the clinician are intended to provide to the referring physician clinically relevant information for diagnosis, surgery and treatment planning.

Source page: https://510kreport.com/device/K041521
Methodology: https://510kreport.com/methodology