# K030870: WBR, Model HR

- Pathway: 510(k) (Special)
- Applicant: U.C.G. Technologies, Ltd.
- Decided: Apr 9, 2003 after 21 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
No predicates in its family tree.
17 later devices descend from it; 1 cites 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)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K072886: Medrad Stellant CT Injector System with P3T, Medrad, Inc. (2007). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K031874: Modification to WBR, Model HR (2003), 16 descendants of its own
- K040370: WBR-FHR, WBR-FWB (2004), 15 descendants of its own
- 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

## Indications for use
The WBR- HR 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/K030870
Methodology: https://510kreport.com/methodology