# K052430: Cardius-1, Cardius-2, Cardius-3, 2020TC Spect Imaging System

- Pathway: 510(k) (Special)
- Applicant: Digirad Corp.
- Decided: Oct 4, 2005 after 28 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: 3 generations back to K885054 (1989). 11 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 19 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 2.
- K030085: Cardius-1 and Cardis-2, Digirad Corp. (2003) Summary page 2.
- K051549: Cardius-1, Cardius-2, Cardius-3, 2020TC Spect Imaging System, Digirad Corp. (2005) Summary page 2.
- K972886: Mirage, Segami Corp., Inc. (1997) Summary page 2.
- K023110: Cedars-Sinai Motion Correction (Moco) Software, Model 111005, Digirad Corp. (2002) Summary page 1.
- K010509: Cedars-Sinai BPGS and Moco, Smv America (2001) Summary page 2.
- K003264: QPS/BPGS/Moco Processing Applications for Entegra Workstation, Ge Medical Systems F.I. Haifa (2000) Summary page 2.

## Most influential descendants
- K070542: Cardius 1, 2 and 3 Xpo and 2020TC Spect Imaging Systems (2007), 6 descendants of its own
- K100838: Ergo Imaging System (2010), 2 descendants of its own
- K082368: Cardius-1, -2, -3, and Cardius 1,2,3 Xpo Spect Imaging Systems, 2020TC Spect Imaging System (2008), 1 descendant of its own
- K123408: Ergo Imaging System (2013), 0 descendants of its own
- K110384: Dilon 6800 Acella (Acella) (2011), 0 descendants of its own

## Indications for use
Cardius-1, Cardius-2, Cardius-3: 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 Imager TM 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/K052430
Methodology: https://510kreport.com/methodology