# K020546: Fusion 7D

- Pathway: 510(k) (Traditional)
- Applicant: Mirada Solutions, Ltd.
- Decided: Apr 26, 2002 after 66 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K954678 (1996). 6 ancestors in all.
442 later devices descend from it; 9 cite it directly.
1 of 449 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010336: Advantage Windows CT/Pet Fusion, Ge Medical Systems, Inc. (2001) Summary page 3.
- K983256: Advantage Windows (AW) Fusion, GE Medical Systems (1998) Summary page 3.
- K992654: Plug 'N View 3D, Version 1.0, Voxar Limited (1999) Summary page 3.

## Most influential descendants
- K071950: Syngo Trued (2007), 201 descendants of its own
- K091373: Syngo Trued (2009), 200 descendants of its own
- K040305: VITREA2 Version 3.5 (2004), 164 descendants of its own
- K043333: VITREA2, Version 3.7 Medical Image Processing System (2004), 143 descendants of its own
- K061214: Aquariusaps Server (2006), 134 descendants of its own

## Indications for use
Fusion7D registers pairs of anatomical and functional volumetric images (e.g. MRI-SPECT, MRI-PET, CT-SPECT, CT-PET), or pairs of anatomical volumetric images (e.g. MRI-MRI, CT-CT and MRI-CT) as a means to ease the comparison of image volume data by the clinician. The result of the registration operation aims to help the clinician obtain a better understanding of the joint information that would otherwise have to be compared visually. This is useful for a wide range of clinical and therapeutic applications. It is important to note that the clinician retains the ultimate responsibility for making the pertinent diagnosis based on their standard procedures including visual comparison of the separate unregistered images. Fusion7D is a complement to these standard procedures.

Source page: https://510kreport.com/device/K020546
Methodology: https://510kreport.com/methodology