# K100714: CSMC Cardiac Suite-Nuclear Medicine Software Applicaton Model 2010-01

- Pathway: 510(k) (Traditional)
- Applicant: Cedars-Sinai Medical Center
- Decided: Apr 1, 2011 after 385 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: 4 generations back to K003264 (2000). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060020: Autoquant Plus, Adac Laboratories (2006) Summary page 2.
- K010509: Cedars-Sinai BPGS and Moco, Smv America (2001) Summary page 2.

## 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/K100714
Methodology: https://510kreport.com/methodology