# K103710: WBR Xpress Pet

- Pathway: 510(k) (Special)
- Applicant: Ultraspect, Ltd.
- Decided: Jan 19, 2011 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: 7 generations back to K030870 (2003). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040370: WBR-FHR, WBR-FWB, Ultraspect, Ltd. (2004) Summary page 1.
- K080784: WBR Xpress.Cardiac, WBR Xpress.Bone; WBR Xact.Cardiac, WBR Xact.Bone, Ultraspect, Ltd. (2008) Summary page 1.
- K091073: WBR Xpress.Cardiac and XPRESS3.Cardiac Including Attenuation and Scattering Corrections, Ultraspect, Ltd. (2009) Summary page 1.
- K040172: Modification to GE Discovery LS System, GE Medical Systems (2004) Summary page 1.

## Indications for use
The WBR Xpress.PET including the Attenuation & Scattering Corrections is indicated for the acquisition, formatting and storage of scintigraphy 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 imaged organs

Source page: https://510kreport.com/device/K103710
Methodology: https://510kreport.com/methodology