# K091073: WBR Xpress.Cardiac and XPRESS3.Cardiac Including Attenuation and Scattering Corrections

- Pathway: 510(k) (Special)
- Applicant: Ultraspect, Ltd.
- Decided: May 14, 2009 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: 6 generations back to K030870 (2003). 12 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080784: WBR Xpress.Cardiac, WBR Xpress.Bone; WBR Xact.Cardiac, WBR Xact.Bone, Ultraspect, Ltd. (2008) Summary page 1.
- K081201: WBR XPRESS3.Cardiac, Ultraspect, Ltd. (2008) Summary page 1.
- K051673: Xeleris 2 Processing and Review Workstation, GE Medical Systems (2005) Summary page 1.

## Most influential descendants
- K103710: WBR Xpress Pet (2011), 0 descendants of its own

## Indications for use
The WBR Xpress3.Cardiac and WBR Xpress.Cardiac including the Attenuation & Scattering Corrections are indicated for the acquisition, formatting and storage of scintigraphy camera output data. They are 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 imaged organs

Source page: https://510kreport.com/device/K091073
Methodology: https://510kreport.com/methodology