510(k) · Cleared
ClearedCSMC Cardiac Suite-Nuclear Medicine Software Applicaton Model 2010-01
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 Apr 1, 2011 as substantially equivalent to K060020 (Adac Laboratories, 2006) and 1 other predicate after a 385-day review. Its family tree reaches back 4 generations to 2000.
- Decided
- Apr 1, 2011
- Review
- 385 days
- Class
- Class II
- Product code
- KPS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K003264 (2000). 6 ancestors in all, the oldest K980715 (1998). No later device cites it as a predicate yet.
- Root · 4 generations backK003264 QPS/BPGS/Moco Processing Applications for Entegra WorkstationGe Medical Systems F.I. Haifa · 2000
- 3 generations backK022428 Quantitative Blood Pool Spect (QBS)Adac Laboratories · 2002
- 2 generations backK040326 Autoquant PlusAdac Laboratories · 2004
- 1 generation backK060020 Autoquant PlusAdac Laboratories · 2006
- This deviceK100714 CSMC Cardiac Suite-Nuclear Medicine Software Applicaton Model 2010-01Cedars-Sinai Medical Center · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K003264 | QPS/BPGS/Moco Processing Applications for Entegra Workstation | Ge Medical Systems F.I. Haifa | 2000 | — |
| −3 | K022428 | Quantitative Blood Pool Spect (QBS) | Adac Laboratories | 2002 | — |
| −2 | K040326 | Autoquant Plus | Adac Laboratories | 2004 | — |
| −1 | K060020 | Autoquant Plus | Adac Laboratories | 2006 | — |
| 0 (this device) | K100714 | CSMC Cardiac Suite-Nuclear Medicine Software Applicaton Model 2010-01 | Cedars-Sinai Medical Center | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2001 | 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? (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 |
|---|---|---|---|
| * | K060020 | Autoquant PlusSummary page 2…Programs Manufacturer Product Name 510(k) No. ADAC Laboratories AutoQUANTO Plus K060020 GE/SMV America Cedars-Sinai BPGS/MoCo Software Programs K010509 PRODUCT NAME 510(k) CLEARANCE… | 2006 |
| * | K010509 | Cedars-Sinai BPGS and MocoSummary page 2…510(k) No. ADAC Laboratories AutoQUANTO Plus K060020 GE/SMV America Cedars-Sinai BPGS/MoCo Software Programs K010509 PRODUCT NAME 510(k) CLEARANCE MANUFACTURER ___________NUMBER DATE AutoQU… | 2001 |
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?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
- None of the 6 ancestors has a 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. 2011, 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 datasets. 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 healthcare 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/K100714 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100714: CSMC Cardiac Suite-Nuclear Medicine Software Applicaton Model 2010-01.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100714
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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