510(k) · Cleared
ClearedCedars-Sinai Cardiac Suite Nuclear Medicine Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cedars-Sinai Medical Center · KPS System, Tomography, Computed, Emission
Cleared on Jul 22, 2014 as substantially equivalent to K112474 (Cedars-Sinai Medical Center, 2011) after a 32-day review. Its family tree reaches back 1 generation to 2011. 1 later device descends from it.
- Decided
- Jul 22, 2014
- Review
- 32 days
- Class
- Class II
- Product code
- KPS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K112474 (2011). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK112474 CSMC Cardiac Suite- Nuclear Medicine SoftwareCedars-Sinai Medical Center · 2011
- This deviceK141652 Cedars-Sinai Cardiac Suite Nuclear Medicine SoftwareCedars-Sinai Medical Center · 2014
- Descendant · cites it directly · 0 of its ownK172609 CSMC Cardiac SuiteCedars-Sinai Medical Center · 2017
Most influential descendants
Showing 1 of 1 · See all- K172609CSMC Cardiac SuiteCedars-Sinai Medical Center · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K112474 | CSMC Cardiac Suite- Nuclear Medicine Software | Cedars-Sinai Medical Center | 2011 | — |
| 0 (this device) | K141652 | Cedars-Sinai Cardiac Suite Nuclear Medicine Software | Cedars-Sinai Medical Center | 2014 | — |
| +1 | K172609 | CSMC Cardiac Suite | Cedars-Sinai Medical Center | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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 |
|---|---|---|---|
| * | K112474 | CSMC Cardiac Suite- Nuclear Medicine SoftwareSummary page 1…y equivalent in intended use, principal of operation and technological characteristics to the previously cleared CSMC Cardiac Suite v20 12- Nuclear Medicine Software (KI 112474). Description of the IDevice Subject to Preniarket Notification: The Cedars-Sinai Cardiac Suite is a stand-alone software solut… | 2011 |
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 |
|---|---|---|---|
| K172609 | CSMC Cardiac Suite | 2017 | 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?
- Its one ancestor has no recall.
- Of its descendants, K172609 (Cedars-Sinai Medical Center, 2017) has gone furthest, with 0 descendants of its own.
How does its category compare?
All KPS devicesKPS System, Tomography, Computed, Emission: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Cedars-Sinai Cardiac Suite of applications is intended to enable an automated display, review, and quantification of Nuclear Medicine Cardiology medical images and dataseta. Cedars-Sinai Cardiac Suite may be used in multiple settings including the hospital clinic, doctors office, or remotely. The results provided should be reviewed by qualified healthicare professionals (e.g., radiologists, cardiologists, or general nuclear medicine physicians) trained in the use of medical imaging devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141652 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141652: Cedars-Sinai Cardiac Suite Nuclear Medicine Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141652
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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