# K233750: ECG-less Cardiac

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems, LLC
- Decided: Apr 2, 2024 after 132 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- 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 K013561 (2001). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213715: Revolution Apex, Revolution Apex Elite, Revolution Apex Plus, Revolution Apex Select,Revolution CT; Revolution CT ES; Revolution CT with Apex edition; Revolution CT ES with Apex edition, Ge Medical Systems, LLC (2021) Summary page 4.

## Indications for use
ECG-less Cardiac streamlines patient preparation by enabling an alternative acquisition of cardiac CT images for general cardiac assessment without the need of a patient-attached ECG monitor. ECG-less Cardiac is for adults only.

Source page: https://510kreport.com/device/K233750
Methodology: https://510kreport.com/methodology