510(k) · Cleared
ClearedWBR Xpress.Cardiac, WBR Xpress.Bone; WBR Xact.Cardiac, WBR Xact.Bone
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ultraspect, Ltd. · KPS System, Tomography, Computed, Emission
Cleared on Apr 2, 2008 as substantially equivalent to K050815 (Ultraspect, Ltd., 2005) after a 13-day review. Its family tree reaches back 4 generations to 2003. 13 later devices descend from it.
- Decided
- Apr 2, 2008
- Review
- 13 days
- Class
- Class II
- Product code
- KPS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K030870 (2003). 7 ancestors in all, the oldest K914350 (1991). 13 later devices descend from it, 4 citing it directly.
- Root · 4 generations backK030870 WBR, Model HRU.C.G. Technologies, Ltd. · 2003
- 3 generations backK031874 Modification to WBR, Model HRU.C.G. Technologies, Ltd. · 2003
- 2 generations backK040370 WBR-FHR, WBR-FWBUltraspect, Ltd. · 2004
- 1 generation backK050815 Xact.Cardiac & Xpress.CardiacUltraspect, Ltd. · 2005
- This deviceK080784 WBR Xpress.Cardiac, WBR Xpress.Bone; WBR Xact.Cardiac, WBR Xact.BoneUltraspect, Ltd. · 2008
- Descendant · cites it directly · 9 of its ownK110507 Cardiac Scanner and Processing SystemSpectrum Dynamics (Israel), Ltd. · 2011
- Descendant · 2 generations on · 5 of its ownK161740 D-SPECT Scanner, D-SPECT L ScannerSpectrum Dynamics Medical, Ltd. · 2016
- Descendant · 3 generations on · 4 of its ownK180514 Veriton NMSpectrum Dynamics Medical, Ltd. · 2018
- Descendant · 4 generations on · 3 of its ownK182484 VERITON CT whole body SPECT/CT systemSpectrum Dynamics Medical, Ltd. · 2018
- Descendant · 5 generations on · 2 of its ownK190457 VERITON CT whole body SPECT/CT systemSpectrum Dynamics Medical, Ltd. · 2019
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K110507Cardiac Scanner and Processing SystemSpectrum Dynamics (Israel), Ltd. · 2011 · cites it directly9descendants
- K161740D-SPECT Scanner, D-SPECT L ScannerSpectrum Dynamics Medical, Ltd. · 2016 · 2 generations on5descendants
- K180514Veriton NMSpectrum Dynamics Medical, Ltd. · 2018 · 3 generations on4descendants
- K182484VERITON CT whole body SPECT/CT systemSpectrum Dynamics Medical, Ltd. · 2018 · 4 generations on3descendants
- K190457VERITON CT whole body SPECT/CT systemSpectrum Dynamics Medical, Ltd. · 2019 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K030870 | WBR, Model HR | U.C.G. Technologies, Ltd. | 2003 | — |
| −3 | K031874 | Modification to WBR, Model HR | U.C.G. Technologies, Ltd. | 2003 | — |
| −2 | K040370 | WBR-FHR, WBR-FWB | Ultraspect, Ltd. | 2004 | — |
| −1 | K050815 | Xact.Cardiac & Xpress.Cardiac | Ultraspect, Ltd. | 2005 | — |
| 0 (this device) | K080784 | WBR Xpress.Cardiac, WBR Xpress.Bone; WBR Xact.Cardiac, WBR Xact.Bone | Ultraspect, Ltd. | 2008 | — |
| +1 | K110507 | Cardiac Scanner and Processing System | Spectrum Dynamics (Israel), Ltd. | 2011 | — |
| +2 | K161740 | D-SPECT Scanner, D-SPECT L Scanner | Spectrum Dynamics Medical, Ltd. | 2016 | — |
| +3 | K180514 | Veriton NM | Spectrum Dynamics Medical, Ltd. | 2018 | — |
| +4 | K182484 | VERITON CT whole body SPECT/CT system | Spectrum Dynamics Medical, Ltd. | 2018 | — |
| +5 | K190457 | VERITON CT whole body SPECT/CT system | Spectrum Dynamics Medical, Ltd. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 2 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2016 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KPS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KPS device
- #1 K253564 uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI…score 18.6 · 17 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K050815 | Xact.Cardiac & Xpress.CardiacSummary page 1…II Product Reason for 510(k) Submission Special 510(k) Submission Identification of Legally Marketed Equivalent Devices WBR Xact.cardiac & Xpress.cardiac - K050815 Device Description The WBR Half dose is a modification of labeling of the legally marketed device. The device is… | 2005 |
What descends from it? (13)
See all 134 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 1.1 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K110507 (Spectrum Dynamics (Israel), Ltd., 2011) has gone furthest, with 9 descendants of its own.
- 1 other device also cites its predicate K050815.
How does its category compare?
All KPS devicesKPS System, Tomography, Computed, Emission: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · KPS
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KPS
65in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KPS
16in 2025
Class I (17 since 2007) Class II/III not classified
Adverse event reports per year · KPS
36in 2025
MAUDE reports naming product code KPS, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 8 | 38 | 22 | 38 |
| 2008 | 17 | 25 | 16 | 11 |
| 2009 | 9 | 42 | 14 | 15 |
| 2010 | 3 | 91 | 4 | 44 |
| 2011 | 7 | 28 | 34 | 56 |
| 2012 | 6 | 94 | 13 | 34 |
| 2013 | 11 | 84 | 13 | 240 |
| 2014 | 11 | 92 | 18 | 33 |
| 2015 | 3 | 112 | 5 | 24 |
| 2016 | 11 | 65 | 16 | 10 |
| 2017 | 11 | 104 | 11 | 31 |
| 2018 | 13 | 59 | 12 (3) | 26 |
| 2019 | 3 | 60 | 5 (5) | 105 |
| 2020 | 12 | 72 | 8 | 22 |
| 2021 | 15 | 66 | 4 | 10 |
| 2022 | 5 | 60 | 8 (6) | 15 |
| 2023 | 12 | 63 | 6 (3) | 22 |
| 2024 | 11 | 59 | 15 | 23 |
| 2025 | 12 | 65 | 16 | 36 |
| 2026 | 6 | 67 | 6 | — |
What is it indicated for?
The WBR Half Dose 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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080784 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080784: WBR Xpress.Cardiac, WBR Xpress.Bone; WBR Xact.Cardiac, WBR Xact.Bone.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080784
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026