# K141652: Cedars-Sinai Cardiac Suite Nuclear Medicine Software

- Pathway: 510(k) (Special)
- Applicant: Cedars-Sinai Medical Center
- Decided: Jul 22, 2014 after 32 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: 1 generation back to K112474 (2011). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112474: CSMC Cardiac Suite- Nuclear Medicine Software, Cedars-Sinai Medical Center (2011) Summary page 1.

## Most influential descendants
- K172609: CSMC Cardiac Suite (2017), 0 descendants of its own

## 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 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.

Source page: https://510kreport.com/device/K141652
Methodology: https://510kreport.com/methodology