510(k) · Cleared
ClearedWBR Xpress.Cardiac and XPRESS3.Cardiac Including Attenuation and Scattering Corrections
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 May 14, 2009 as substantially equivalent to K080784 (Ultraspect, Ltd., 2008) and 2 other predicates after a 30-day review. Its family tree reaches back 6 generations to 2003. 1 later device descends from it.
- Decided
- May 14, 2009
- Review
- 30 days
- Class
- Class II
- Product code
- KPS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K030870 (2003). 12 ancestors in all, the oldest K914350 (1991). 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK030870 WBR, Model HRU.C.G. Technologies, Ltd. · 2003
- 5 generations backK031874 Modification to WBR, Model HRU.C.G. Technologies, Ltd. · 2003
- 4 generations backK040370 WBR-FHR, WBR-FWBUltraspect, Ltd. · 2004
- 3 generations backK050815 Xact.Cardiac & Xpress.CardiacUltraspect, Ltd. · 2005
- 2 generations backK080784 WBR Xpress.Cardiac, WBR Xpress.Bone; WBR Xact.Cardiac, WBR Xact.BoneUltraspect, Ltd. · 2008
- 1 generation backK081201 WBR XPRESS3.CardiacUltraspect, Ltd. · 2008
- This deviceK091073 WBR Xpress.Cardiac and XPRESS3.Cardiac Including Attenuation and…Ultraspect, Ltd. · 2009
- Descendant · cites it directly · 0 of its ownK103710 WBR Xpress PetUltraspect, Ltd. · 2011
Most influential descendants
Showing 1 of 1 · See all- K103710WBR Xpress PetUltraspect, Ltd. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K030870 | WBR, Model HR | U.C.G. Technologies, Ltd. | 2003 | — |
| −5 | K031874 | Modification to WBR, Model HR | U.C.G. Technologies, Ltd. | 2003 | — |
| −4 | K040370 | WBR-FHR, WBR-FWB | Ultraspect, Ltd. | 2004 | — |
| −3 | K050815 | Xact.Cardiac & Xpress.Cardiac | Ultraspect, Ltd. | 2005 | — |
| −2 | K080784 | WBR Xpress.Cardiac, WBR Xpress.Bone; WBR Xact.Cardiac, WBR Xact.Bone | Ultraspect, Ltd. | 2008 | — |
| −1 | K081201 | WBR XPRESS3.Cardiac | Ultraspect, Ltd. | 2008 | — |
| 0 (this device) | K091073 | WBR Xpress.Cardiac and XPRESS3.Cardiac Including Attenuation and Scattering… | Ultraspect, Ltd. | 2009 | — |
| +1 | K103710 | WBR Xpress Pet | Ultraspect, Ltd. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 2 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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? (3)
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 |
|---|---|---|---|
| * | K080784 | WBR Xpress.Cardiac, WBR Xpress.Bone; WBR Xact.Cardiac, WBR Xact.BoneSummary page 1…Class II Product Reason for 510(k) Submission Special 510(k) Submission Identification of Legally Marketed Predicate Devices Xpress.cardiac - K080784, Xpress3.cardiac - K081201 Xeleris - K051673 Device Description The Xpress.cardiac & Xpress3.cardiac are image pro… | 2008 |
| * | K081201 | WBR XPRESS3.CardiacSummary page 1…Reason for 510(k) Submission Special 510(k) Submission Identification of Legally Marketed Predicate Devices Xpress.cardiac - K080784, Xpress3.cardiac - K081201 Xeleris - K051673 Device Description The Xpress.cardiac & Xpress3.cardiac are image processing systems, which are… | 2008 |
| * | K051673 | Xeleris 2 Processing and Review WorkstationSummary page 1…bmission Special 510(k) Submission Identification of Legally Marketed Predicate Devices Xpress.cardiac - K080784, Xpress3.cardiac - K081201 Xeleris - K051673 Device Description The Xpress.cardiac & Xpress3.cardiac are image processing systems, which are interfaced to gamm… | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K103710 | WBR Xpress Pet | 2011 | 0 |
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 6 years and passes through 2 companies; a new generation was cleared every 12 months on median.
- 3 of the 12 ancestors have a recall of any class.
- Of its descendants, K103710 (Ultraspect, Ltd., 2011) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K080784.
How does its category compare?
All KPS devicesKPS System, Tomography, Computed, Emission: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091073 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091073: WBR Xpress.Cardiac and XPRESS3.Cardiac Including Attenuation and Scattering Corrections.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091073
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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