RTHawk is an accessory to 1.5T and 3.0T whole-body magnetic 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 Heart Vista 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

Device Description

RTHawk is a software system designed from the ground up to provide a platform for efficient real-time MRI data acquisition, data transfer, image reconstruction, and interactive scan control and display of static and dynamic MR imaging data.

RTHawk is as an accessory to clinical 1.5T and 3.0T MR systems, operating alongside, and in parallel with, the MR scanner console with no permanent physical modifications to the MRI system required.

RTHawk is designed to run on a stand-alone linux-based computer workstation, color monitor, keyboard and mouse. It is designed to operate alongside, and in parallel with, the existing MR console with no hardware modifications required to be made to the MR system or console. This RTHawk Workstation is sourced by the Customer in conformance with HeartVista-provided specifications, and verified prior to installation.

A private ethernet network connects the RTHawk workstation to the MR scanner computer. When not in use, the RTHawk workstation may be detached from the MR scanner with no detrimental, residual impact upon MR scanner function, operation, or throughput.

The RTHawk application is written to run on top of the Linux operating system, much like application software for word processing, accounting, graphics, etc. Additional software is installed on the MR scanner computer, for receiving communications and control commands from RTHawk, and for directing MRI raw data to RTHawk for image reconstruction, display and processing.

RTHawk is an easy-to-use, yet fully functional, MR Operating System environment. The RTHawk operating system has been designed to provide a platform for the real-time acquisition, control, reconstruction, display, and storage of high-quality static and dynamic MRI images and data.

Data is continuously acquired and displayed. By user interaction or data feedback, fundamental scan parameters can be modified. Real-time and high-resolution image acquisition methods are used throughout RTHawk for scan plane localization, for tracking of patient motion, for detection of transient events, for on-the-fly, sub-second latency adjustment of image acquisition parameters (e.g., scan plane, flip angle, field-of-view, etc.) and for image visualization. Additional features are provided to automate and facilitate the set of tasks performed during a typical cardiac exam.

Conventional MR scanners queue an entire scan ahead of time and provide for little or no modification to a scan already in progress. Conversely, the RTHawk software prepares scan waveforms just as they are needed. RTHawk's efficient management of pulse sequence waveforms and instructions for modifying those pulse sequence waveforms uses the entire scanning interval for preparation of the next sequence. Scan parameters may be manipulated in real time, while providing all checks necessary to assure patient safety.

RTHawk makes extensive use of spiral image acquisition techniques to maximize scan efficiency. While conventional scans acquire data line-by-line in a Cartesian grid, RTHawk collects data more efficiently in a spiral pattern. Spiral-pattern raw data must be reformatted for correct reconstruction and display, requiring additional computing resources and image correction procedures to reduce image artifacts and distortions, ensuring high-quality reconstructed images.

RTHawk implements the conventional MRI concept of Protocols. Protocols are pre-set by HeartVista, but new protocols can be created and modified by the end user.

RTHawk Apps (Applications) are comprised of a pulse sequence, predefined fixed and adjustable parameters, reconstruction pipeline(s), and a tailored graphical user interface containing image visualization and scan control tools. RTHawk Apps may provide real-time interactive scanning, conventional) batch-mode scanning, accelerated scanning, or calibration functions, in which data acquired may be used to tune or optimize other Apps.

The HeartVista Cardiac Package is a collection of RTHawk APPs that enables the performance of a comprehensive cardiovascular MR (CMR) study in a clinically feasible amount of time. These APPs are designed and optimized to acquire, reconstruct, and display CMR images, with features including:

On-the-fly, sub-second latency adjustment of image acquisition parameters (e.g., scan plane, flip angle, field-of-view, etc.)
. Real-time imaging, enabling less reliance on ECG gating and artifact suppression techniques. Real-time imaging may be used for scan plane localization, instantaneous tracking of patient motion, and clinical user observation of transient events
Scan automation tools including automatic pushbutton localization of standard cardiac . views, automatic determination of inversion time, automatic detection of artifacts, and automated myocardial segmentation
High spatial resolution imaging, including single breath-hold, multi-slice high-resolution GRE app offering near total heart coverage
Free-breathing, multi-slice SSFP and GRE apps that rapidly acquire high-quality images ● - potentially useful for patients who suffer from arrhythmia or who cannot hold their breath
. Multi-slice dynamic SR GRE app with one heartbeat temporal resolution for time-course imaging.
Continuous flow quantification

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information derived from the provided text for the RTHawk, HeartVista Cardiac Package (K183274):

1. Table of Acceptance Criteria and Reported Device Performance

The provided document doesn't explicitly state quantitative acceptance criteria for device performance for the novel features introduced in K183274 compared to its predicate. Instead, it focuses on the device's adherence to regulatory standards and its functional equivalence/enhancements.

The "Performance Data - Discussion of Non-Clinical Tests" section (Page 7-8) lists the types of non-clinical tests performed, which essentially serve as verification that the device functions correctly and safely. The acceptance criteria for these would be compliance with the listed standards and satisfactory results for internal quality assurance measures.

Acceptance Criteria (Implied by Non-Clinical Tests & Compliance to Standards):

Acceptance Criteria Category	Specifics / Standard	Reported Device Performance
Safety	Maximum SAR	First level controlled (< 4W/kg whole-body)
	Maximum dB/dt	First level controlled
	Acoustic Noise	Compliant with MS4-2010
Image Quality	SNR	Compliant with MS1-2008
	Uniformity	Compliant with MS3-2008
Functional / Software	Code Reviews	Satisfactory
	Design Reviews	Satisfactory
	Unit & Integration Testing	Satisfactory
	System & Manual Testing	Satisfactory
Regulatory Compliance	Electrical Safety	Compliant with IEC 60601-2-33 Ed 3.0, ES60601-1
	Risk Management	Compliant with ISO 14971:2007
	DICOM Compatibility	Compliant with NEMA PS3.1 - 3.20 (2011)
	Software Quality	Compliant with ES60601-1 (PEMS section)
Equivalence to Predicate	Indications for Use	Identical
	Technological Characteristics	Substantially equivalent (with enhancements)

Note: The document only states "First level controlled" for SAR and dB/dt, implying compliance with safety limits but not giving specific numerical values. Similarly, for SNR and uniformity, it states "Compliant with," indicating favorable results without providing raw performance metrics.

2. Sample Size Used for the Test Set and Data Provenance

The provided document does not explicitly describe a "test set" in terms of patient data for evaluating the clinical performance of the device's new features (like automated segmentation or new cardiac apps). The focus of the performance data discussion is on non-clinical engineering and software validation.

Therefore, information regarding:

Sample size used for the test set: Not provided in terms of patient data.
Data provenance (country of origin, retrospective/prospective): Not provided.

The "verification testing" mentioned on page 7 refers to internal software and system testing, not necessarily clinical validation with patient data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Since the document does not detail a clinical study with patient data for algorithm performance, there is no information provided regarding:

Number of experts used to establish ground truth: Not mentioned.
Qualifications of those experts: Not mentioned.

Ground truth is only implicitly referred to in the context of a "trained physician" interpreting images to assist in diagnosis (page 2, Indications for Use).

4. Adjudication Method for the Test Set

As there is no specific clinical test set described, there is no information provided regarding an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not mention or describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. There is no information about human readers improving with AI assistance vs. without AI assistance. This submission focuses on the device's functional and safety equivalence and expanded features rather than its impact on physician performance.

6. Standalone (Algorithm Only) Performance Study

The information provided does not explicitly present a standalone performance study of the algorithm (e.g., for automated segmentation) with quantitative metrics. The new features like "Automated myocardial segmentation" are listed as enhancements but no performance data for these specific features in standalone mode is provided in this summary.

7. Type of Ground Truth Used for Performance Evaluation

Given the lack of a detailed clinical performance study in the provided text for the novel features, the type of ground truth used is not specified. The document leans heavily on compliance with engineering and safety standards, and functional equivalence to the predicate device. For potential future clinical performance assessments of features like "Automated myocardial segmentation," pathology or expert consensus would typically be used as ground truth, but this is not detailed here.

8. Sample Size for the Training Set

The document does not provide any information regarding the sample size for a training set. This K183274 submission is an update to a previously cleared device (K170090) and details software enhancements and new "Apps." While machine learning components (like the automated segmentation or artifact detection) would typically involve training data, this specific summary does not disclose those details.

9. How Ground Truth for the Training Set Was Established

Similar to point 8, since no training set information is provided, how the ground truth for any potential training set was established is also not detailed in this document.

Summary

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October 18, 2019

HeartVista, Inc. % Mr. James J. Rogers FDA Regulatory Affairs, Quality Assurance, and Clinical Studies 4984 El Camino Real, Suite 102 LOS ALTOS CA 94022

Re: K183274

Trade/Device Name: RTHawk, HeartVista Cardiac Package Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH Dated: September 19, 2019 Received: September 20, 2019

Dear Mr. Rogers:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

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https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K183274

Device Name RTHawk, HeartVista Cardiac Package

Indications for Use (Describe)

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

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

RTHawk; HeartVista Cardiac Package 510(k) Number: K183274

Submitted in accordance with the requirements of SMDA 1990 and 21CFR 807.92.

1.0 Medical Establishment Registration

Medical Establishment Registration No .: 3011767965

2.0 Contact Information

James Jochen Rogers FDA Regulatory Affairs, Quality Assurance, and Clinical Studies T: 724.713.2298 E: jr@heartvista.com

3.0 Establishment Name and Address

HeartVista, Inc. 4984 El Camino Real, Suite 102 Los Altos, CA 94022

4.0 Submission Date

November 19, 2018, September 19, 2019, October 15, 2019

5.0 Device Information

Trade/Proprietary Name: RTHawk, HeartVista Cardiac Package Common Name: RTHawk, HeartVista Cardiac Package Model Number(s):

HeartVista Cardiac Package (HVCP) ●
. RTHawk

Regulation Number: 892.1000

Regulation Name: Magnetic resonance diagnostic device (MRDD)

Regulatory Class: Class II

Device Classification Name: System, Nuclear Magnetic Resonance Imaging

Classification Panel: Radiology

Classification Product Code(s): LNH

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6.0 Predicate Device(s)

510(k) #	Device	510(k) Sponsor	510(k) ClearanceDate
K170090	RTHawk (ver 2.3.2)HeartVista Cardiac Package	HeartVista	07/14/2017

7.0 Device Description

RTHawk is as an accessory to clinical 1.5T and 3.0T MR systems, operating alongside, and in parallel with, the MR scanner console with no permanent physical modifications to the MRI system required.

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of transient events, for on-the-fly, sub-second latency adjustment of image acquisition parameters (e.g., scan plane, flip angle, field-of-view, etc.) and for image visualization. Additional features are provided to automate and facilitate the set of tasks performed during a typical cardiac exam.

RTHawk implements the conventional MRI concept of Protocols. Protocols are pre-set by HeartVista, but new protocols can be created and modified by the end user.

On-the-fly, sub-second latency adjustment of image acquisition parameters (e.g., scan plane, flip angle, field-of-view, etc.)
. Real-time imaging, enabling less reliance on ECG gating and artifact suppression techniques. Real-time imaging may be used for scan plane localization, instantaneous tracking of patient motion, and clinical user observation of transient events
Scan automation tools including automatic pushbutton localization of standard cardiac . views, automatic determination of inversion time, automatic detection of artifacts, and automated myocardial segmentation

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Image /page/6/Picture/0 description: The image shows the word "HEARTVISTA" in a stylized, futuristic font. The letters are black and bold, with sharp angles and geometric shapes. Above the letter "I" is a small, cyan-colored dot, which serves as the dot for the "i". The overall design is modern and eye-catching.

High spatial resolution imaging, including single breath-hold, multi-slice high-resolution GRE app offering near total heart coverage
Free-breathing, multi-slice SSFP and GRE apps that rapidly acquire high-quality images ● - potentially useful for patients who suffer from arrhythmia or who cannot hold their breath
. Multi-slice dynamic SR GRE app with one heartbeat temporal resolution for time-course imaging.
Continuous flow quantification

Operating Modes IEC 60601-2-33 (2010-03)

The conventional MRI concept of anatomy- and indication-specific Protocols is implemented within the HeartVista Cardiac Package. APPs within the HeartVista Cardiac Package are organized into basic Protocols pre-set by HeartVista. The clinical user may modify APP parameters from default values within their ranges. These modified APPs may be saved into new or existing user-created Protocols to create unique CMR-indicated protocols tailored to the user's clinical interests.

Safety Parameter	Safety Level
Magnetic Field strength	1.5T, 3.0T

FIRST LEVEL CONTROLLED

OPERATING MODE

< 4W/kg whole-body

OPERATING MODE

SAR, dB/dt

RTHawk operates compatible MR scanners within the safety parameters listed below:

8.0 Indications for Use

Safety Parameter Display

Max SAR

Max dB/dt

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.

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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

9.0 Performance Data - Discussion of Non-Clinical Tests

Design controls quality assurance measures during the development of RTHawk include:

Code reviews ●
Design reviews ●
Unit and integration level testing
. Verification testing, including System and Manual testing
Safety testing, including SAR, dB/dt, and acoustic noise .
Performance testing, including SNR and uniformity
. Validation testing

RTHawk has been designed to comply with the FDA Recognized Consensus Standards listed in the table below, as applicable to device features and components:

Reference #	Title
IEC 60601-2-33 Ed 3.0(2010-03)	Medical electrical equipment - Part 2-33: Particularrequirements for the basic safety and essential performance ofmagnetic resonance equipment for medical diagnostic(radiology).
MS1-2008	Determination of Signal-to-Noise Ratio (SNR) in DiagnosticMagnetic Resonance Imaging
MS3-2008	Determination of Image Uniformity in Diagnostic MagneticResonance Images
MS4-2010	Acoustic Noise Measurement Procedure for DiagnosticMagnetic Resonance Imaging Devices
MS8-2008	Characterization of the Specific Absorption Rate (SAR) forMagnetic Resonance Imaging Systems
NEMA PS3.1 - 3.20 (2011)	Digital Imaging And Communications In Medicine (DICOM)Set.

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ISO 14971:2007	Medical Devices - Application Of Risk Management To' Medical Devices
ES60601-1:2005/(R)2012+A1 +C1 +A2	(Consolidated Text) Medical Electrical Equipment - Part 1:General Requirements For Basic Safety And EssentialPerformance (IEC 60601-1:2005, Mod). Section 14Programmable Electrical Medical Systems (PEMS)

Risk management, compliant with ISO 14971:2007, identified hazards, sequences of events, and resultant harms; developed, implemented, and tested risk-controlling mitigations; and evaluated residual risks.

10.0 Technological Characteristics Comparison to Predicate Device and Discussion

Both the subject device and the predicate device software are intended as an accessory to GEHC 1.5T and 3.0T MRI systems, and are intended to integrate and interact seamlessly with the operating system software within those MRI systems. Both devices support all coils available on the specific installation's MRI console. Neither device supports software-controlled patient table movements and shifts. Both devices support remote access to and imaging on the specific installation's MRI system.

The structure of the subject device software is identical to the predicate device software, and is comprised of the following functional modules:

. Acquisition - responsible for the transfer of MR raw data from the MR scanner to the HeartVista Workstation
. Analysis - contains the image post-processing tools
. Application - HeartVista APPs. Each APP is comprised of a pulse sequence, user parameters, a reconstruction pipeline, and a specific user interface
Information System - the central repository of all relevant MRI system configuration, patient, study, scan, etc., parameters associated with the current patient study
. Reconstruction - responsible for the efficient processing of raw data to generate MR images via a flexible, pipelined topology
. Scan Control - responsible for the real-time network transfer of controlling orders for APPs, APPs parameters modifications, and dynamic information from the MR host in response to user or program requests
Sequencer - creates and provides a specific set of pulse sequence waveforms to control the MR scanner
. Storage - obtains current patient and scan information, performs non-volatile local storage, exports images and data in DICOM format, and logs events.

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Visualization - implements all aspects of the user interface, including APP selection, controls to modify APP parameters, image display, graphical slice prescription, and image review, save, and export.
As with the predicate device, RTHawk Apps (Applications) are comprised of a pulse sequence, predefined fixed and adjustable parameters, reconstruction pipeline(s), and a tailored graphical user interface containing image visualization and scan control tools. RTHawk Apps provide real-time interactive, batch-mode, and accelerated scanning, as well as calibration functions, in which data acquired may be used to tune or optimize other Apps. Orthogonal, oblique, and double oblique imaging planes are fully supported. The HeartVista Cardiac Package is a collection of RTHawk Apps designed to acquire, reconstruct and display cardiovascular MR (CMR) images.

In this version of the HeartVista Cardiac Package, notable changes include:

. The operating system intended for use with the HeartVista Cardiac Package is now Ubuntu 18.04 ("Bionic"), released April 2018.
Additional compatibility with GE Signa scanners with software revision DV 26. ●
The addition of new CMR Apps including: ●
- B0 Mapping о
- Cardiac Localizer o
- O Cardiac T2 Map
- Cardiac T2* Map Cartesian O
- Cartesian Shimming O
- O FB DE GRE
- FB MS Tagging GRE O
- Multi-Slice Cine Flow O
- Multi-Slice DE SSFP O
- Noise Measurement O
- Stack-of-Spiral Cine Flow o
Additional variations on existing APPs, including
- O Automating the determination and prescription of standard cardiac views (short-axis, fourchamber, etc.)
- The optional addition of L1-based denoising ("Compressed Sensing") to O some Apps
- The ability to automatically detect artifacts in some Apps O
- o Automation of the breath-holding process through automatic voice
- Automated determination of an optimal TI value from Cine DE Cal data O
New features intended to address cybersecurity concerns ●
The ability to automatically segment LV endocardium, LV epicardium, and RV ● endocardium

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Instructions for use are included within the device labeling, and the information provided enables the user to operate the device in a safe and effective manner. The subject device implements FDA Unique Device Identifier (UDI) labeling requirements. Both devices have equivalent statements of Intended Use.

The table below summarizes a comparison of the revised technological characteristics to the predicate device:

Attribute	Predicate DeviceK170090RTHawk (ver 2.3.2)HeartVista Cardiac Package	Modified DeviceK183274RTHawk (ver 2.5.1)HeartVista Cardiac Package
Indications for Use	RTHawk is an accessory to 1.5Tand 3.0T whole-body magneticresonance diagnostic devices(MRDD or MR). It is intended tooperate alongside, and in parallelwith, the existing MR console toacquire traditional, real-time, andaccelerated images. TheHeartVista Cardiac Package is acollection of RTHawk Appsdesigned to acquire, reconstructand display cardiovascular MR(CMR) images.RTHawk produces static anddynamic transverse, coronal,sagittal, and obliquecross-sectional images that displaythe internal structures and/orfunctions of the entire body. Theimages produced reflect the spatialdistribution of nuclei exhibitingmagnetic resonance. The magneticresonance properties thatdetermine image appearance areproton density, spin-latticerelaxation time (T1), spin-spinrelaxation time (T2) and flow. Wheninterpreted by a trained physician,these images provide information	RTHawk is an accessory to 1.5Tand 3.0T whole-body magneticresonance diagnostic devices(MRDD or MR). It is intended tooperate alongside, and in parallelwith, the existing MR console toacquire traditional, real-time, andaccelerated images. TheHeartVista Cardiac Package is acollection of RTHawk Appsdesigned to acquire, reconstructand display cardiovascular MR(CMR) images.RTHawk produces static anddynamic transverse, coronal,sagittal, and obliquecross-sectional images that displaythe internal structures and/orfunctions of the entire body. Theimages produced reflect the spatialdistribution of nuclei exhibitingmagnetic resonance. The magneticresonance properties thatdetermine image appearance areproton density, spin-latticerelaxation time (T1), spin-spinrelaxation time (T2) and flow. Wheninterpreted by a trained physician,these images provide information
	that may assist in the determinationof a diagnosis.	that may assist in the determinationof a diagnosis.
	RTHawk is intended for use as anaccessory to the following MRIsystems:Manufacturer: GE Healthcare(GEHC)Field Strength: 1.5T and 3.0TScanner Software Versions: 12, 15,16, 23, 24, 25	RTHawk is intended for use as anaccessory to the following MRIsystems:Manufacturer: GE Healthcare(GEHC)Field Strength: 1.5T and 3.0TScanner Software Versions: 12, 15,16, 23, 24, 25, 26
Magnetic FieldStrength(s)	1.5T, 3.0T	1.5T, 3.0T
Imaging Planes	Transverse, Coronal, Sagittal,Oblique, Double Oblique	Transverse, Coronal, Sagittal,Oblique, Double Oblique
Time CourseImaging	Yes	Yes
Parameter Mapping	T1, T2*	T1, T2, T2*
Ventricular Function	Free-Breathing and Breath-Held	Free-Breathing and Breath-Held
MDE	Free-Breathing and Breath-Held	Free-Breathing and Breath-Held
Gated MRA	Yes	Yes
Black BloodImaging	Yes	Yes
SPAMM Tagging	No	Yes
Flow Imaging	Real-Time	Real-Time, Multi-Slice, and 4D
Remote Scanningand Support	Yes	Yes
Automated ScanPlanning	No	Yes

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11.0 Conclusions

Based upon verification testing and compliance with voluntary standards, the Company believes that RTHawk, and the HeartVista Cardiac Package, are substantially equivalent to the predicate device, and do not raise any new questions of safety or effectiveness.

Regulation Number and Section

N/A