# K082458: P3T Abdomen

- Pathway: 510(k) (Traditional)
- Applicant: Medrad, Inc.
- Decided: Oct 17, 2008 after 52 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K934086 (1995). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072886: Medrad Stellant CT Injector System with P3T, Medrad, Inc. (2007) Summary page 1.

## Indications for use
P3TTM Abdomen automates the calculation of individual contrast injection protocols, based on patient characteristics and contrast concentration. P3TTM Abdomen is a software application for use on a laptop computer. P3TTM Abdomen is indicated for use with CT angiography of abdominal organs (i.e., liver, pancreas, kidneys).

Source page: https://510kreport.com/device/K082458
Methodology: https://510kreport.com/methodology