510(k) · Cleared
ClearedWBR XPRESS3.Cardiac
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 28, 2008 as substantially equivalent to K050815 (Ultraspect, Ltd., 2005) and 1 other predicate after a 30-day review. Its family tree reaches back 5 generations to 2003. 2 later devices descend from it.
- Decided
- May 28, 2008
- Review
- 30 days
- Class
- Class II
- Product code
- KPS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K030870 (2003). 8 ancestors in all, the oldest K914350 (1991). 2 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK030870 WBR, Model HRU.C.G. Technologies, Ltd. · 2003
- 4 generations backK031874 Modification to WBR, Model HRU.C.G. Technologies, Ltd. · 2003
- 3 generations backK040370 WBR-FHR, WBR-FWBUltraspect, Ltd. · 2004
- 2 generations backK050815 Xact.Cardiac & Xpress.CardiacUltraspect, Ltd. · 2005
- 1 generation backK080784 WBR Xpress.Cardiac, WBR Xpress.Bone; WBR Xact.Cardiac, WBR Xact.BoneUltraspect, Ltd. · 2008
- This deviceK081201 WBR XPRESS3.CardiacUltraspect, Ltd. · 2008
- Descendant · cites it directly · 1 of its ownK091073 WBR Xpress.Cardiac and XPRESS3.Cardiac Including Attenuation and…Ultraspect, Ltd. · 2009
- Descendant · 2 generations on · 0 of its ownK103710 WBR Xpress PetUltraspect, Ltd. · 2011
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K030870 | WBR, Model HR | U.C.G. Technologies, Ltd. | 2003 | — |
| −4 | K031874 | Modification to WBR, Model HR | U.C.G. Technologies, Ltd. | 2003 | — |
| −3 | K040370 | WBR-FHR, WBR-FWB | Ultraspect, Ltd. | 2004 | — |
| −2 | K050815 | Xact.Cardiac & Xpress.Cardiac | Ultraspect, Ltd. | 2005 | — |
| −1 | K080784 | WBR Xpress.Cardiac, WBR Xpress.Bone; WBR Xact.Cardiac, WBR Xact.Bone | Ultraspect, Ltd. | 2008 | — |
| 0 (this device) | K081201 | WBR XPRESS3.Cardiac | Ultraspect, Ltd. | 2008 | — |
| +1 | K091073 | WBR Xpress.Cardiac and XPRESS3.Cardiac Including Attenuation and Scattering… | Ultraspect, Ltd. | 2009 | — |
| +2 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 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 18.7 · 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? (2)
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 Lmsally Marketed Predicate Devices WBR Xact.cardiac & Xpress.cardiac - K0508 15 including Half Dose K080784 Device Description The Xpress3.cardiac is an image processing system, which is interfac… | 2005 |
| * | K080784 | WBR Xpress.Cardiac, WBR Xpress.Bone; WBR Xact.Cardiac, WBR Xact.BoneSummary page 1…ssion Special 510(k) Submission Identification of Lmsally Marketed Predicate Devices WBR Xact.cardiac & Xpress.cardiac - K0508 15 including Half Dose K080784 Device Description The Xpress3.cardiac is an image processing system, which is interfaced to gamma cameras. Gamma c… | 2008 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K091073 | WBR Xpress.Cardiac and XPRESS3.Cardiac Including Attenuation and Scattering Corrections | 2009 | 1 |
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 8 months on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K091073 (Ultraspect, Ltd., 2009) has gone furthest, with 1 descendant 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 Xpress3.Cardiac 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/K081201 · printed Nov 4, 2026
Cite this page
510(k) Report. “K081201: WBR XPRESS3.Cardiac.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K081201
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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