# K050366: Imagenpro

- Pathway: 510(k) (Traditional)
- Applicant: Cardiovascular Imaging Technologies, LLC
- Decided: Mar 17, 2005 after 31 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 K010641 (2001). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002584: Ecat Accel Pet Scanner, Cti Pet Systems, Inc. (2000) Summary page 1.
- K023988: GE Discovery LS System, GE Medical Systems (2003) Summary page 1.

## Most influential descendants
- K173547: ImagenUniversal (2018), 0 descendants of its own

## Indications for use
The ImagenPROTM system is software that allows the user to visualize raw PET and/or PET/CT data, reconstruct myocardial perfusion PET or PET/CT images and reorient PET and/or PET/CT reconstructed tomograms.

Source page: https://510kreport.com/device/K050366
Methodology: https://510kreport.com/methodology