# K153740: RTHawk, HeartVista Cardiac Package

- Pathway: 510(k) (Traditional)
- Applicant: Heartvista, Inc.
- Decided: Jun 30, 2016 after 185 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K962061 (1996). 12 ancestors in all.
4 later devices descend from it; 1 cites it directly.
4 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142997: RTHawk, HeartVista Workstation with RTHawk, Heartvista, Inc. (2014) Summary page 5.

## Most influential descendants
- K170090: RTHawk, HeartVista Cardiac Package (2017), 3 descendants of its own
- K183274: RTHawk, HeartVista Cardiac Package (2019), 2 descendants of its own
- K212233: RTHawk, HeartVista Cardiac Package (2021), 1 descendant of its own
- K251029: Vista OS, Vista AI Scan, RTHawk (2025), 0 descendants of its own

## Indications for use
RTHawk is an accessory to 1.5T and 3.0T whole-body magnetic resonance diagnostic devices (MRDD or MR). It is intended to operate alongside, and in parallel with, the existing MR console to acquire traditional, real-time and accelerated images. The HeartVista Cardiac Package is a collection of RTHawk Apps designed to acquire, reconstruct and display cardiovascular MR (CMR) images. RTHawk produces static and dynamic transverse, coronal, sagittal, and oblique cross-sectional images that display the internal structures and/or functions of the entire body. The images produced reflect the spatial distribution of nuclei exhibiting magnetic resonance. The magnetic resonance properties that determine image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that may assist in the determination of a diagnosis. RTHawk is intended for use as an accessory to the following MRI systems: Manufacturer: GE Healthcare (GEHC) Field Strength: 1.5T and 3.0T Scanner Software Versions: 15, 16, 23, 24, 25

Source page: https://510kreport.com/device/K153740
Methodology: https://510kreport.com/methodology