# K201933: ImagenSPECT 3.0

- Pathway: 510(k) (Special)
- Applicant: Cardiovascular Imaging Technologies
- Decided: Aug 11, 2020 after 29 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: 5 generations back to K952674 (1995). 16 ancestors in all.
No later device cites it as a predicate yet.
1 of 17 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152503: ImagenSPECT, Cardiovascular Imaging Technologies (2016) Summary page 4.
- K023190: E.Cam Computer / E.Soft Workstation, Siemens Medical Solutions USA, Inc. (2002) Summary page 4.

## Indications for use
The ImagenSPECT™ 3.0 system is a software application that provides a processing environment for the analysis and display of cardiac SPECT and planar images. The results of this processing may be used in determining the presence of cardiac diseases. Data for ImagenSPECT 3.0 is derived from a nuclear medicine gamma camera. The resulting datasets may be either planar or 3D tomograms of patient anatomy. This software can also be used for processing display and quantitation of multigated acquisition blood pool scans (MUGA) specifically the left ventricular ejection fraction (LVEF). ImagenSPECT™ 3.0 can also be used for quantitation of planar and SPECT, early and late 99mTc pyrophosphate images.

Source page: https://510kreport.com/device/K201933
Methodology: https://510kreport.com/methodology