# K133848: Rthawk, Rthawk, or Heartvista Workstation with Rthawk

- Pathway: 510(k) (Traditional)
- Applicant: Heartvista, Inc.
- Decided: Jun 25, 2014 after 189 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: 4 generations back to K962061 (1996). 10 ancestors in all.
6 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)
- K041476: GE Signa Excite 1.5T MR System, GE Signa Excite 3.0T MR System, Ge Medical Systems, LLC (2004) Summary page 1.

## Most influential descendants
- K142997: RTHawk, HeartVista Workstation with RTHawk (2014), 5 descendants of its own
- K153740: RTHawk, HeartVista Cardiac Package (2016), 4 descendants of its own
- 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

## Indications for use
The HeartVista Workstation with the RTHawk application software is an accessory to I.5T and 3.OT whole-body magnetic resonance diagnostic devices (MRDD or.MR). The HeartVista Workstation with the RTHawk application software is intended to operate alongside, and in parallel with, the existing MR console to acquire real-time and accelerated images. The HeartVista Workstation with the RTHawk application software is indicated for Cardiovascular MR (CMR) applications. The HeartVista Workstation with the RTI-awk application software 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 (TI), 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. The HeartVista Workstation with the RTHawk application software is intended for use as an accessory to the following OEM, MRI system, and software release versions: *GE Healthcare (GEHC) Signa H-Dxt 1.5T. 3.OT. Software versions 15 and 16.

Source page: https://510kreport.com/device/K133848
Methodology: https://510kreport.com/methodology