# K010336: Advantage Windows CT/Pet Fusion

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems, Inc.
- Decided: Feb 16, 2001 after 11 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
494 later devices descend from it; 9 cite it directly.
1 of 495 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K020546: Fusion 7D (2002), 442 descendants of its own
- K041484: Undecided (2004), 222 descendants of its own
- K053301: Cedara I-Response Cedara Pet/CT (2006), 221 descendants of its own
- K071950: Syngo Trued (2007), 201 descendants of its own
- K091373: Syngo Trued (2009), 200 descendants of its own

## Recalls of this device
- May 24, 2012 · Class II · Z-1960-2012: GE Healthcare has become aware of a potential safety issue due to incorrect alignment of fused CT and PET images associated with the CT/PET fusion capabilities of your Volume Viewer and CT/PET Fusion 
- Oct 8, 2004 · Not classified · Z-0854-06: Display in fused mode- viewer allows 2 studies ( PET/CT) registered in the same spatial domain to be viewed simultaneously. These 2 images should be visually aligned to a precision of less than 1/2 PE

Source page: https://510kreport.com/device/K010336
Methodology: https://510kreport.com/methodology