Radiology · 510(k) · 2019
RTHawk, HeartVista Cardiac Package
HeartVista, Inc.. Cleared by FDA on 18 October 2019 under submission K183274, product code LNH (system, nuclear magnetic resonance imaging). What FDA's record says, in FDA's words.
Device record · K183274
- Device. RTHawk, HeartVista Cardiac PackageDEVICE
- Company. HeartVista, Inc.COMPANY
- Decision. 18 October 2019, 510(k), substantially equivalent (traditional review); received 23 November 2018DECISION
- Panel. RadiologyPANEL
- Product code. LNH, System, Nuclear Magnetic Resonance ImagingCODE
- Regulation. 21 CFR 892.1000, Class IIREG
- Source. FDA database entry · decision document (12 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
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: 12, 15, 16, 23, 24, 25, 26
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Modalities namedMRI
- Mentionsa diagnostic claim
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 4,787 reports filed against devices carrying product code LNH. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
29 September 2026 · Malfunction · Achieva 1.5T Dstream · Philips Medical Systems Nederland B.V. · report 3042177665-2026-000174
28 September 2026 · Malfunction · Achieva 1.5T · Philips Medical Systems Nederland B.V. · report 3042177665-2026-000166
Philips received a report that the Quadrature Body Coil (QBC) seal on the front cover is coming loose. This seal is used for protection, to avoid the patient from potentially contacting the sharp edges of the Magnet covers.If this seal is loose, it is likely that this could lead to serious injury.
28 September 2026 · Malfunction · Ingenia · Philips Medical Systems Nederland B.V. · report 3042177665-2026-000167
Philips received a report that the upper Quadrature Body Coil (QBC) seal has peeling off. This seal is used for protection, to avoid the patient from potentially contacting the sharp edges of the Magnet covers.If this seal is peeled it is likely that this could lead to serious injury.
28 September 2026 · Malfunction · Ingenia · Philips Medical Systems Nederland B.V. · report 3042177665-2026-000168
Philips received a report that the Quadrature Body Coil (QBC) seal has come loose. This seal is used for protection, to avoid the patient from potentially contacting the sharp edges of the Magnet covers.If this seal comes loose it is likely that this could lead to serious injury.
28 September 2026 · Malfunction · Ingenia · Philips Medical Systems Nederland B.V. · report 3042177665-2026-000169
Philips received a report that the upper Quadrature Body Coil (QBC) seal has come loose This seal is used for protection, to avoid the patient from potentially contacting the sharp edges of the Magnet covers.If this seal is loose it is likely that this could lead to serious injury.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code LNH, in Radiology, or cleared in 2019. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.