# K081201: WBR XPRESS3.Cardiac

- Pathway: 510(k) (Special)
- Applicant: Ultraspect, Ltd.
- Decided: May 28, 2008 after 30 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 K030870 (2003). 8 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050815: Xact.Cardiac & Xpress.Cardiac, Ultraspect, Ltd. (2005) Summary page 1.
- K080784: WBR Xpress.Cardiac, WBR Xpress.Bone; WBR Xact.Cardiac, WBR Xact.Bone, Ultraspect, Ltd. (2008) Summary page 1.

## Most influential descendants
- K091073: WBR Xpress.Cardiac and XPRESS3.Cardiac Including Attenuation and Scattering Corrections (2009), 1 descendant of its own
- K103710: WBR Xpress Pet (2011), 0 descendants of its own

## Indications for use
The Xpress3.Cardiac is indicated for the acquisition, formatting and storage of scintigraphy camera output data. It is capable of processing and displaying the acquired information in traditional formats, as well as in pseudo three dimensional renderings, and in various forms of animated sequences, showing kinetic attributes of the image organs

Source page: https://510kreport.com/device/K081201
Methodology: https://510kreport.com/methodology