# K030085: Cardius-1 and Cardis-2

- Pathway: 510(k) (Special)
- Applicant: Digirad Corp.
- Decided: Feb 5, 2003 after 27 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
No predicates in its family tree.
9 later devices descend from it; 4 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Digirad 2020tc SPECT Imaging System: named in the summary without a submission number
- (no number) ADAC Forte (cardiac applications only): named in the summary without a submission number

## Most influential descendants
- K051549: Cardius-1, Cardius-2, Cardius-3, 2020TC Spect Imaging System (2005), 8 descendants of its own
- K052430: Cardius-1, Cardius-2, Cardius-3, 2020TC Spect Imaging System (2005), 7 descendants of its own
- 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

## Indications for use
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.

Source page: https://510kreport.com/device/K030085
Methodology: https://510kreport.com/methodology