RTHawk, HeartVista Cardiac Package

K170090 · Heartvista, Inc. · LNH · Jul 14, 2017 · Radiology

Device Facts

• Record ID: K170090
• Device Name: RTHawk, HeartVista Cardiac Package
• Applicant: Heartvista, Inc.
• Product Code: LNH · Radiology
• Decision Date: Jul 14, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1000
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended 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.

Device Story

RTHawk is a software platform accessory for 1.5T/3.0T GE MRI systems; operates in parallel with existing MR console via private ethernet connection; requires no permanent hardware modifications. Input: raw MR data from scanner. Processing: Linux-based workstation runs RTHawk Apps (pulse sequences, reconstruction pipelines, GUI); enables real-time parameter adjustment (scan plane, flip angle, FOV), motion tracking, and artifact suppression. Output: static/dynamic cross-sectional images (transverse, coronal, sagittal, oblique) displayed on workstation monitor. Used in clinical settings by trained physicians/technicians to assist diagnosis. Benefits: enables comprehensive cardiovascular MR studies in clinically feasible time; supports free-breathing imaging for patients with arrhythmia or breath-hold limitations; provides continuous flow quantification.

Clinical Evidence

Bench testing only. No clinical data presented. Verification and validation testing included code reviews, unit/integration testing, system/manual testing, and safety/performance testing per consensus standards (IEC 60601-2-33, NEMA MS1/MS3/MS4/MS8).

Technological Characteristics

Software-only accessory running on Linux-based workstation. Connectivity: private ethernet to GE MRI console. Imaging: 1.5T/3.0T MR. Standards: IEC 60601-2-33, NEMA PS3.1-3.20, ISO 14971:2007, ES60601-1. Features: real-time pulse sequence control, pipelined raw data reconstruction, DICOM export. Supports up to 32-channel coils. No patient table movement control.

Indications for Use

Indicated for use as an accessory to GE Healthcare 1.5T and 3.0T MRI systems for acquiring, reconstructing, and displaying cardiovascular MR images and general body cross-sectional images to assist physicians in diagnosis.

Regulatory Classification

Identification

A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).

Special Controls

*Classification.* Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Predicate Devices

• RTHawk (ver 2.3.0) HeartVista Cardiac Package (K153740)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized caduceus, which is a symbol often associated with healthcare and medicine.

July 14, 2017

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

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

Re: K170090

Trade/Device Name: RTHawk. HeartVista Cardiac Package Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: June 13, 2017 Received: June 16, 2017

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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D. O'Hara
For

Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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#### Indications for Use

510(k) Number (if known) K170090

Device Name RTHawk, HeartVista Cardiac Package

#### Indications for Use (Describe)

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

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

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Image /page/3/Picture/0 description: The image shows the word "HEARTVISTA" in a stylized font. The letters "HEARTVIS" are in black, while the "TA" is in red. There is a red dot above the letter "I" in "VISTA". The font is bold and geometric, giving the word a modern and technological look.

## 510(k) Summary

RTHawk; HeartVista Cardiac Package 510(k) Number: K170090

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: [e-mail]

### 3.0 Establishment Name and Address

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

## 4.0 Submission Date

January 5, 2017, June 13, 2017

#### 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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Image /page/4/Picture/0 description: The image shows the logo for Heartvista. The logo is black except for the last letter, which is red, and a dot above the "i", which is also red. The logo is in a stylized font.

### 6.0 Predicate Device(s)

| 510(k) # | Device | 510(k) Sponsor | 510(k) Clearance<br>Date |
|----------|--------------------------------------------------|----------------|--------------------------|
| K153740 | RTHawk (ver 2.3.0)<br>HeartVista Cardiac Package | HeartVista | 06/30/2016 |

## 7.0 Device Description

RTHawk is a software platform intended for the efficient real-time MRI data acquisition, data transfer, image reconstruction, and interactive scan control and display of static and dynamic MR imaging data.

As an accessory to clinical 1.5T and 3.0T MR systems, RTHawk operates 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, with color monitor, keyboard and mouse. A private ethernet network connects the RTHawk workstation to the MR scanner computer. When not in use, the RTHawk workstation may be disconnected from the MR scanner with no detrimental, residual impact upon MR scanner function, operation, or throughput.

RTHawk is a linux operating system-level software application that is intended to control the MR scanner, acquiring high quality, real-time MRI image data and performing post-processing. The RTHawk software includes optimized image acquisition applications, a pipelined raw data image reconstruction engine, a rich graphical user interface for interactive scan control, real-time adjustment of pulse sequence parameters, and display of reconstructed images, and drivers and protocols for communications with, and control of, the OEM MR scanner console.

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:

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Image /page/5/Picture/0 description: The image shows the word "HEARTVISTA" in a stylized font. The first part of the word, "HEARTVIS", is in black, while the "TA" is in red. There is a red dot above the "I" in "VISTA". The font is modern and geometric.

- 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
- . 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

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.

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<br>(2010-03) | Medical electrical equipment - Part 2-33: Particular<br>requirements for the basic safety and essential performance of<br>magnetic resonance equipment for medical diagnostic<br>(radiology). |
| MS1-2008 | Determination of Signal-to-Noise Ratio (SNR) in Diagnostic<br>Magnetic Resonance Imaging |
| MS3-2008 | Determination of Image Uniformity in Diagnostic Magnetic<br>Resonance Images |
| MS4-2010 | Acoustic Noise Measurement Procedure for Diagnostic<br>Magnetic Resonance Imaging Devices |
| MS8-2008 | Characterization of the Specific Absorption Rate (SAR) for<br>Magnetic Resonance Imaging Systems |
| NEMA PS3.1 - 3.20 (2011) | Digital Imaging And Communications In Medicine (DICOM)<br>Set. |

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Image /page/6/Picture/0 description: The image shows the word "HEARTVISTA" in a stylized font. The letters "HEART" are in black, while the "A" is in red. There is a red dot above the "I" in "VISTA".

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

### 8.0 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 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

# 9.0 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.

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Image /page/7/Picture/0 description: The image shows the word "HEARTVISTA" in a stylized font. The first five letters, "HEART", are in black, blocky letters. The "I" in "VISTA" is dotted with a red circle, and the "A" is red and shaped like an upside-down "V". The overall design is modern and eye-catching.

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 con guration, 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.
- . 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, and functions and features of those Apps is unchanged from the predicate device.

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 Device | Modified Device |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | K153740<br>RTHawk (ver 2.3.0)<br>HeartVIsta Cardiac Package | K170090<br>RTHawk (ver 2.3.2)<br>HeartVIsta Cardiac Package |
| Indications for Use | RTHawk is an accessory to 1.5T<br>and 3.0T whole-body magnetic<br>resonance diagnostic devices<br>(MRDD or MR). It is intended to<br>operate alongside, and in parallel<br>with, the existing MR console to<br>acquire traditional, real-time, and<br>accelerated images. The<br>HeartVista Cardiac Package is a<br>collection of RTHawk Apps<br>designed to acquire, reconstruct<br>and display cardiovascular MR<br>(CMR) images. | RTHawk is an accessory to 1.5T<br>and 3.0T whole-body magnetic<br>resonance diagnostic devices<br>(MRDD or MR). It is intended to<br>operate alongside, and in parallel<br>with, the existing MR console to<br>acquire traditional, real-time, and<br>accelerated images. The<br>HeartVista Cardiac Package is a<br>collection of RTHawk Apps<br>designed to acquire, reconstruct<br>and display cardiovascular MR<br>(CMR) images. |
| | RTHawk produces static and<br>dynamic transverse, coronal,<br>sagittal, and oblique<br>cross-sectional images that display<br>the internal structures and/or<br>functions of the entire body. The<br>images produced reflect the spatial<br>distribution of nuclei exhibiting<br>magnetic resonance. The magnetic<br>resonance properties that<br>determine image appearance are<br>proton density, spin-lattice<br>relaxation time (T1), spin-spin<br>relaxation time (T2) and flow. When<br>interpreted by a trained physician,<br>these images provide information<br>that may assist in the determination<br>of a diagnosis. | RTHawk produces static and<br>dynamic transverse, coronal,<br>sagittal, and oblique<br>cross-sectional images that display<br>the internal structures and/or<br>functions of the entire body. The<br>images produced reflect the spatial<br>distribution of nuclei exhibiting<br>magnetic resonance. The magnetic<br>resonance properties that<br>determine image appearance are<br>proton density, spin-lattice<br>relaxation time (T1), spin-spin<br>relaxation time (T2) and flow. When<br>interpreted by a trained physician,<br>these images provide information<br>that may assist in the determination<br>of a diagnosis. |
| | RTHawk is intended for use as an<br>accessory to the following MRI<br>systems:<br>Manufacturer: GE Healthcare<br>(GEHC)<br>Field Strength: 1.5T and 3.0T | RTHawk is intended for use as an<br>accessory to the following MRI<br>systems:<br>Manufacturer: GE Healthcare<br>(GEHC)<br>Field Strength: 1.5T and 3.0T |
| | Scanner Software Versions: 15, 16,<br>23, 24, 25 | Scanner Software Versions: 12, 15,<br>16, 23, 24, 25 |
| Magnetic Field<br>Strength | 1.5T, 3.0T | 1.5T, 3.0T |
| RF Coils | Up to 32-channel Head, Body,<br>Surface, Phased Array. Supports<br>all coils that are currently available<br>on the MRI console | Up to 32-channel Head, Body,<br>Surface, Phased Array. Supports<br>all coils that are currently available<br>on the MRI console |
| Shaft/Advance<br>Table | No | No |
| Imaging Planes | Transverse, Coronal, Sagittal,<br>Oblique, Double Oblique | Transverse, Coronal, Sagittal,<br>Oblique, Double Oblique |
| Pulse Sequences | | |
| | Cine Cartesian SSFP | Cine Cartesian SSFP |
| | Cine Spiral SSFP | Cine Spiral SSFP |
| | Gated High-Res GRE | Gated High-Res GRE |
| | Gated Double-IR FSE | Gated Double-IR FSE |
| | Time Course GRE | Time Course GRE |
| | FB DE GRE Cal | FB DE GRE Cal |
| | Cine DE Cal | Cine DE Cal |
| | Multi-Slice DE GRE | Multi-Slice DE GRE |
| | FB DE SSFP | FB DE SSFP |
| | Cardiac T1 Map | Cardiac T1 Map |
| | Single-BH 3D DE GRE | Single-BH 3D DE GRE |
| | Real-Time Loc GRE | Real-Time Loc GRE |
| | Real-Time Loce SSFP | Real-Time Loce SSFP |
| | Real-Time Color PC | Real-Time Color PC |
| | FB Multi-Slice GRE | FB Multi-Slice GRE |
| | HART GRE | HART GRE |
| | FB Multi-Slice SSFP | FB Multi-Slice SSFP |
| | HART SSFP | HART SSFP |
| | Gated 3D MRA GRE | Gated 3D MRA GRE |
| | Nav 3D DE GRE | Nav 3D DE GRE |
| | Cardiac T2* Map | Cardiac T2* Map |
| Remote Imaging<br>and Support | Yes | Yes |

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Image /page/8/Picture/0 description: The image shows the word "HEARTVISTA" in a stylized font. The word is mostly in black, except for the last letter "A" which is in red. There is also a red dot above the "I" in "VISTA". The font is modern and geometric.

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Image /page/9/Picture/0 description: The image shows the word "HEARTVISTA" in a stylized font. The word is mostly black, except for the last letter, "A", which is red. There is also a red dot above the "I" in "VISTA".

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Image /page/10/Picture/0 description: The image shows the word "HEARTVISTA" in a stylized font. The letters "HEARTVIS" are in black, while the "TA" is in red. There is a red dot above the "I" in "VISTA". The font is bold and geometric, with sharp angles and straight lines.

## 10.0 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 ●

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.

## 11.0 Safety Parameters

| Safety Parameter | Safety Level |
|---------------------------------------------|--------------------------|
| Magnetic Field strength | 1.5T, 3.0T |
| Operating Modes IEC 60601-2-33<br>(2010-03) | 1st Level Operating Mode |
| Safety Parameter Display | SAR, dB/dt |
| Max SAR | < 4W/kg whole-body |
| Max dB/dt | 1st Level Operating Mode |

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Image /page/11/Picture/0 description: The image shows the word "HEARTVISTA" in a stylized font. The word is primarily in black, except for the last letter, "A", which is in red. There is also a red dot above the "i" in "VISTA". The font is modern and geometric, giving the word a sleek and technological appearance.

## 12.0 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.