510(k) · Cleared
ClearedModificarion to Wackers-Liu CQ Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eclipse Systems, Inc. · KPS System, Tomography, Computed, Emission
Cleared on Aug 25, 2003 as substantially equivalent to K002229 (Eclipse Systems, Inc., 2000) after a 12-day review. Its family tree reaches back 1 generation to 2000.
- Decided
- Aug 25, 2003
- Review
- 12 days
- Class
- Class II
- Product code
- KPS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K002229 (2000). No later device cites it as a predicate yet.
- Root · 1 generation backK002229 Wackers-Liu CQ SoftwareEclipse Systems, Inc. · 2000
- This deviceK032500 Modificarion to Wackers-Liu CQ SoftwareEclipse Systems, Inc. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002229 | Wackers-Liu CQ Software | Eclipse Systems, Inc. | 2000 | — |
| 0 (this device) | K032500 | Modificarion to Wackers-Liu CQ Software | Eclipse Systems, Inc. | 2003 | — |
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 |
|---|---|---|---|
| * | K002229 | Wackers-Liu CQ SoftwareSummary page 1…ssion Computed Tomography System and Medical Image Digitizer 4. PREDICATE DEVICE Wackers-Liu CQ" Software (K002229) 5. DEVICE DESCRIPTION The revised Wackers-Liu CQ" Software is a stand-alone software package. Thi… | 2000 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
How does its category compare?
All KPS devicesKPS System, Tomography, Computed, Emission: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 revised Wackers-Liu CQ" Software is a stand-alone software package for quantification of emission computed tomography (ECT) myocardial perfusion images. The data generated by the Wackers-Liu CQ" Software is intended to be used by the physician in addition to other complementary data in the evaluation of cardiac fknction and blood supply. It is not meant to replace or eliminate the physician's standard visual interpretation of the patient study or the…
Read the full statement (109 words)
The revised Wackers-Liu CQ" Software is a stand-alone software package for quantification of emission computed tomography (ECT) myocardial perfusion images. The data generated by the Wackers-Liu CQ" Software is intended to be used by the physician in addition to other complementary data in the evaluation of cardiac fknction and blood supply. It is not meant to replace or eliminate the physician's standard visual interpretation of the patient study or the integration of additional clinical andor diagnostic information (patient history, stress andor rest EKG, echocardiogram, etc.) prior to making any final clinical diagnostic or treatment decision. The Wackers-Liu CQ" Software also provides for transmission of ECT images over the internet.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032500 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032500: Modificarion to Wackers-Liu CQ Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032500
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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