# K083649: Cardius 3 X-Act

- Pathway: 510(k) (Traditional)
- Applicant: Digirad Corp.
- Decided: Mar 9, 2009 after 90 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: 6 generations back to K885054 (1989). 22 ancestors in all.
No later device cites it as a predicate yet.
6 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080927: Brightview VCT Imaging System, Philips Medical Systems (Cleveland), Inc. (2008) Summary page 1.
- K070542: Cardius 1, 2 and 3 Xpo and 2020TC Spect Imaging Systems, Digirad Corp. (2007) Summary page 1.
- K082368: Cardius-1, -2, -3, and Cardius 1,2,3 Xpo Spect Imaging Systems, 2020TC Spect Imaging System, Digirad Corp. (2008) Summary page 1.

## Indications for use
The Cardius 3 X-ACT Imaging System is a gamma camera for Single Photon Emission Computed Tomography (SPECT) integrated with an attenuation device consisting of an x-ray generator. The Cardius 3 X-ACT Imaging System is intended for use in the generation of cardiac studies, including planar and SPECT studies, in nuclear medicine applications. Cardius 3 X-ACT produces non-attenuation corrected SPECT Images and attenuation corrected SPECT images with x-ray transmission data that may also be corrected for scatter.

Source page: https://510kreport.com/device/K083649
Methodology: https://510kreport.com/methodology