# K042692: Clarity Fusion

- Pathway: 510(k) (Special)
- Applicant: Shared P.E.T. Imaging, LLC
- Decided: Oct 7, 2004 after 7 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: 1 generation back to K032866 (2003). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032866: Clarity Pet, Shared P.E.T. Imaging, LLC (2003) Summary page 1.

## Indications for use
To detect or image the distribution of radionuclides in the body or organ, using the following techniques: * Multiplanar Reconstruction (MPR) * Maximum/Minimum Intensity Projection (MIP) * Image Contrast Manipulation * Image Zoom Manipulation * Automatic registration with Mutual Information Technique

Source page: https://510kreport.com/device/K042692
Methodology: https://510kreport.com/methodology