# K042839: C-Pet Plus Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems (Cleveland), Inc.
- Decided: Oct 29, 2004 after 15 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
Longest line of descent: 2 generations back to K930428 (1993). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973396: Quest Pet Imaging System, Ugm Medical Systems, Inc. (1998) Summary page 1.
- K033782: Allegro Imaging System, Philips Medical Systems (Cleveland), Inc. (2003) Summary page 1.

## Indications for use
The device is a Positron Emission Tomography (PET) Imaging System. It is intended to produce images depicting the anatomical distributions of single photon and positron emitting radioisotopes with the human body for interpretation by medical personnel.

Source page: https://510kreport.com/device/K042839
Methodology: https://510kreport.com/methodology