# K192277: CardIQ Flow

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems SCS
- Decided: Feb 14, 2020 after 176 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: 10 generations back to K913770 (1991). 55 ancestors in all.
No later device cites it as a predicate yet.
1 of 56 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171303: Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664, University of Texas Medical School AT Houston, Texas (2017) Summary page 5.
- K061587: Fullcard Analysis, GE Healthcare (2006) Summary page 5.

## Indications for use
CardIQ Flow is an aiding tool for the clinicians to perform analysis of sets of stationary, dynamic, or gated cardiac positron emission tomography (PET) images. The measurements include perfusion, end-diastolic & end-systolic volumes, stroke volume, ejection fraction, myocardial mass, and transient ischemic dilatation. Also included is a feature that enables clinicians to visualize reformatted data and make a comparison between stress and rest series. Software is indicated for determining regional and global absolute rest and stress myocardial perfusion in cc/min/g, Coronary Flow Reserve and their combination into the Coronary Flow Capacity (CFC) Map in patients with suspected or known coronary artery disease (CAD) in order to assist clinical interpretation of PET perfusion images by quantification of their severity. It is intended for use by trained professionals, such as nuclear technicians, nuclear medicine or nuclear cardiology physicians, or cardiologists with appropriate training. The clinician remains ultimately responsible for the final assessment and diagnosis based on standard practices, clinical judgment and interpretation of cardiac images or quantitative data.

Source page: https://510kreport.com/device/K192277
Methodology: https://510kreport.com/methodology