# K032866: Clarity Pet

- Pathway: 510(k) (Traditional)
- Applicant: Shared P.E.T. Imaging, LLC
- Decided: Dec 12, 2003 after 88 days
- Product code: KPS (System, Tomography, Computed, Emission)
- Device class: 2
- Regulation: 21 CFR 892.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K0001276: Medical Image Merge. Number could not be read

## Most influential descendants
- K042692: Clarity Fusion (2004), 0 descendants of its own

## 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/K032866
Methodology: https://510kreport.com/methodology