# K172609: CSMC Cardiac Suite

- Pathway: 510(k) (Special)
- Applicant: Cedars-Sinai Medical Center
- Decided: Nov 3, 2017 after 64 days
- Product code: KPS (System, Tomography, Computed, Emission)
- Device class: 2
- Regulation: 21 CFR 892.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K112474 (2011). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141652: Cedars-Sinai Cardiac Suite Nuclear Medicine Software, Cedars-Sinai Medical Center (2014) Summary page 4.

## Indications for use
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.

Source page: https://510kreport.com/device/K172609
Methodology: https://510kreport.com/methodology