# K033782: Allegro Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems (Cleveland), Inc.
- Decided: Dec 19, 2003 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: 1 generation back to K003434 (2000). 1 ancestor in all.
67 later devices descend from it; 2 cite it directly.
0 of 69 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003434: Allegro TB, Allegro N, Adac Laboratories (2000) Summary page 1.

## Most influential descendants
- K041955: Gemini Pet/CT Imaging System (2004), 65 descendants of its own
- K062650: EP Navigator Software (2006), 49 descendants of its own
- K101311: EP Navigator R3 (2010), 41 descendants of its own
- K111245: Heartnavigator Release 1 (2011), 39 descendants of its own
- K121781: Echonavigator Release 1 (2012), 32 descendants of its own

## 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/K033782
Methodology: https://510kreport.com/methodology