# K152503: ImagenSPECT

- Pathway: 510(k) (Traditional)
- Applicant: Cardiovascular Imaging Technologies
- Decided: Jan 25, 2016 after 145 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: 4 generations back to K952674 (1995). 15 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 17 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061029: Jetstream Workspace, Adac Laboratories (2006) Summary page 4.
- K023190: E.Cam Computer / E.Soft Workstation, Siemens Medical Solutions USA, Inc. (2002) Summary page 4.
- K090403: Autospect, Philips Medical Systems (Cleveland), Inc. (2009) Summary page 4.

## Most influential descendants
- K201933: ImagenSPECT 3.0 (2020), 0 descendants of its own

## Indications for use
The ImagenSPECT™ system is a software application that provides a processing environment for the analysis and display of cardiac SPECT images. The results of this processing may be used in determining the presence of cardiac diseases. Data for ImagenSPECT is derived from a nuclear medicine gamma camera. The resulting datasets may be either planar or 3D tomograms of patient anatomy.

Source page: https://510kreport.com/device/K152503
Methodology: https://510kreport.com/methodology