510(k) · Cleared

Cleared

CSMC Cardiac Suite

K172609510(k) SpecialCleared Nov 3, 201764-day reviewClass II21 CFR 892.1200

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Cedars-Sinai Medical Center · KPS System, Tomography, Computed, Emission

Cleared on Nov 3, 2017 as substantially equivalent to K141652 (Cedars-Sinai Medical Center, 2014) after a 64-day review. Its family tree reaches back 2 generations to 2011.

Decided: Nov 3, 2017
Review: 64 days
Class: Class II
Product code: KPS
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K112474 (2011). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK112474 CSMC Cardiac Suite- Nuclear Medicine SoftwareCedars-Sinai Medical Center · 2011
1 generation backK141652 Cedars-Sinai Cardiac Suite Nuclear Medicine SoftwareCedars-Sinai Medical Center · 2014
This deviceK172609 CSMC Cardiac SuiteCedars-Sinai Medical Center · 2017

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K112474	CSMC Cardiac Suite- Nuclear Medicine Software	Cedars-Sinai Medical Center	2011	—
−1	K141652	Cedars-Sinai Cardiac Suite Nuclear Medicine Software	Cedars-Sinai Medical Center	2014	—
0 (this device)	K172609	CSMC Cardiac Suite	Cedars-Sinai Medical Center	2017	—

FIG. 1 — Lineage of K172609, 2011–2017Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K141652	Cedars-Sinai Cardiac Suite Nuclear Medicine Software Summary page 4 …II CLASSIFICATION: REGULATION 892.1200 NUMBER PRODUCT CODE KPS PREDICATE DEVICES: CSMC Cardiac Suite- Nuclear Medicine Software (K141652) Substantially Equivalent To: The CSMC Cardiac Suite v2017- Nuclear Medicine Software is substantially equivalent in intended u…	Cedars-Sinai Medical Center	2014	—

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 6 years and passes through 1 company; a new generation was cleared every 3.3 years on median.
None of the 2 ancestors has a recall.

How does its category compare?

All KPS devices

KPS System, Tomography, Computed, Emission: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.

FDA decisions per year · KPS

12in 2025

2007high 17 (2008) · low 3 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KPS

65in 2025

2007high 112 (2015) · low 25 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KPS

16in 2025

2007high 34 (2011) · low 4 (2010)2026

Class I (17 since 2007) Class II/III not classified

Adverse event reports per year · KPS

36in 2025

2007high 240 (2013) · low 10 (2016)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/K172609 · printed Nov 6, 2026

Cite this page

510(k) Report. “K172609: CSMC Cardiac Suite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172609

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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