# K040370: WBR-FHR, WBR-FWB

- Pathway: 510(k) (Special)
- Applicant: Ultraspect, Ltd.
- Decided: Mar 11, 2004 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
Longest line of descent: 2 generations back to K030870 (2003). 2 ancestors in all.
15 later devices descend from it; 2 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031874: Modification to WBR, Model HR, U.C.G. Technologies, Ltd. (2003) Summary page 1.

## Most influential descendants
- K050815: Xact.Cardiac & Xpress.Cardiac (2005), 14 descendants of its own
- K080784: WBR Xpress.Cardiac, WBR Xpress.Bone; WBR Xact.Cardiac, WBR Xact.Bone (2008), 13 descendants of its own
- K110507: Cardiac Scanner and Processing System (2011), 9 descendants of its own
- K161740: D-SPECT Scanner, D-SPECT L Scanner (2016), 5 descendants of its own
- K180514: Veriton NM (2018), 4 descendants of its own

## Indications for use
The WBR - fHR, WBR - fWB 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 image organs.

Source page: https://510kreport.com/device/K040370
Methodology: https://510kreport.com/methodology