# K082368: Cardius-1, -2, -3, and Cardius 1,2,3 Xpo Spect Imaging Systems, 2020TC Spect Imaging System

- Pathway: 510(k) (Special)
- Applicant: Digirad Corp.
- Decided: Sep 12, 2008 after 25 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 K885054 (1989). 13 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982855: Digirad 2020TC Spect Imaging System, Digirad Corp. (1998) Summary page 1.
- K030085: Cardius-1 and Cardis-2, Digirad Corp. (2003) Summary page 1.
- K051549: Cardius-1, Cardius-2, Cardius-3, 2020TC Spect Imaging System, Digirad Corp. (2005) Summary page 1.
- K052430: Cardius-1, Cardius-2, Cardius-3, 2020TC Spect Imaging System, Digirad Corp. (2005) Summary page 1.
- K070542: Cardius 1, 2 and 3 Xpo and 2020TC Spect Imaging Systems, Digirad Corp. (2007) Summary page 1.

## Most influential descendants
- K083649: Cardius 3 X-Act (2009), 0 descendants of its own

## Indications for use
Cardius-1, Cardius-2, Cardius-3, Cardius 1 XPO, Cardius 2 XPO, Cardius 3 XPO Imaging Systems: The Cardius product models are intended for use in the generation of cardiac studies, including planar and Single Photon Emission Computed Tomography (SPECT) studies, in nuclear medicine applications. 2020tc SPECT Imaging System: The Digirad 2020tc SPECT Imaging system is intended for use in the generation of both planar and Single Photon Emission Computed Tomography (SPECT) clinical images in nuclear medicine applications. The Digirad SPECT Rotating Chair is used in conjunction with the Digirad 2020tc ImagerTM to obtain SPECT images in patients who are seated in an upright position. Specifically, the 2020tc ImagerTM is intended to image the distribution of radionuclides in the body by means of a photon radiation detector. In so doing, the system produces images depicting the anatomical distribution of radioisotopes within the human body for interpretation by authorized medical personnel.

Source page: https://510kreport.com/device/K082368
Methodology: https://510kreport.com/methodology