Who is the manufacturer of RTHawk, HeartVista Cardiac Package?

Heartvista, Inc. filed the 510(k) submission for RTHawk, HeartVista Cardiac Package (K212233).

What is the FDA product code for RTHawk, HeartVista Cardiac Package?

LNH. It is classified under 21 CFR 892.1000 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for RTHawk, HeartVista Cardiac Package?

510(k) clearance (submission type: Traditional).

What are the predicate devices for RTHawk, HeartVista Cardiac Package?

RTHawk, HeartVista Cardiac Package (K183274).

Who can help prepare an FDA 510(k) submission like RTHawk, HeartVista Cardiac Package?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

RTHawk, HeartVista Cardiac Package

K212233 · Heartvista, Inc. · LNH · Oct 5, 2021 · Radiology

Device Facts

Record ID	K212233
Device Name	RTHawk, HeartVista Cardiac Package
Applicant	Heartvista, Inc.
Product Code	LNH · Radiology
Decision Date	Oct 5, 2021
Decision	SESE
Submission Type	Traditional
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. RTHawk is intended for use as an accessory to the following MRI systems: Manufacturers: GE Healthcare (GEHC), Siemens Healthineers Field Strength: 1.5T and 3.0T GE Software Versions: 12, 15, 16, 23, 24, 25, 26 Siemens Software Versions: N4/VE; NX/VA

Device Story

RTHawk is a software-based accessory for 1.5T/3.0T MRI scanners; operates in parallel with existing MR console via private ethernet connection; requires no hardware modifications. System uses Linux-based workstation to manage pulse sequence waveforms, data acquisition, and image reconstruction. Employs spiral image acquisition for efficiency; provides real-time interactive scan control, automated cardiac localization, and myocardial segmentation. Physician uses RTHawk interface to adjust scan parameters (flip angle, FOV, plane) in sub-second latency; enables real-time visualization of transient events and motion tracking. Reduces reliance on ECG gating/breath-holding. Output consists of high-quality static/dynamic CMR images for diagnostic interpretation. Benefits include improved workflow efficiency, reduced scan times, and high-quality imaging for patients with arrhythmias or breath-hold limitations.

Clinical Evidence

Bench testing only. Verification and validation testing included code reviews, unit/integration testing, system/manual testing, and safety testing (SAR, dB/dt, acoustic noise). Performance testing confirmed SNR and image uniformity per MS1-2008 and MS3-2008 standards. Risk management performed per ISO 14971.

Technological Characteristics

Software-based accessory running on Linux workstation. Connects via private ethernet to MR scanner. Uses spiral acquisition techniques. Complies with IEC 60601-1 (PEMS), IEC 60601-2-33, NEMA MS1, MS3, MS4, MS8, and DICOM standards. Supports 1.5T/3.0T GE and Siemens systems. No hardware modifications to MR scanner.

Indications for Use

Indicated for patients requiring cardiovascular MR (CMR) imaging on 1.5T or 3.0T GE or Siemens MRI systems. Used for acquiring, reconstructing, and displaying static/dynamic cross-sectional images of internal body structures/functions based on proton density, T1, T2, and flow properties to assist physician 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, HeartVista Cardiac Package (K183274)

Related Devices

K183274 — RTHawk, HeartVista Cardiac Package · Heartvista, Inc. · Oct 18, 2019
K153740 — RTHawk, HeartVista Cardiac Package · Heartvista, Inc. · Jun 30, 2016
K170090 — RTHawk, HeartVista Cardiac Package · Heartvista, Inc. · Jul 14, 2017
K133848 — RTHAWK, RTHAWK, OR HEARTVISTA WORKSTATION WITH RTHAWK · Heartvista, Inc. · Jun 25, 2014
K142997 — RTHawk, HeartVista Workstation with RTHawk · Heartvista, Inc. · Dec 17, 2014

Submission Summary (Full Text)

{0}------------------------------------------------ October 5, 2021. Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. HeartVista, Inc % Mr. James J. Rogers Regulatory & Clinical Affairs and Strategic Quality Assurance 2625 Middlefield Rd., #710 PALO ALTO CA 94306 Re: K212233 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 17, 2021 Received: September 22, 2021 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ #### Indications for Use 510(k) Number (if known) K212233 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: Manufacturers: GE Healthcare (GEHC), Siemens Healthineers Field Strength: 1.5T and 3.0T GE Software Versions: 12, 15, 16, 23, 24, 25, 26 Siemens Software Versions: N4/VE; NX/VA | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------| | <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the word "HEARTVISTA" in all caps and in a stylized, futuristic font. The letters are black, except for a small blue dot above the "I". The font is bold and angular, giving the word a modern and technological feel. The overall design is simple yet eye-catching. ### 510(k) Summary RTHawk; HeartVista Cardiac Package 510(k) Number: K212233 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. 2625 Middlefield Road, #710 Palo Alto CA 94306 ### 4.0 Submission Date July 14, 2021 #### 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 {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the word "HEARTVISTA" in a stylized, bold, black font. A small, light blue dot is positioned above the letter "i" in "VISTA". The font appears modern and geometric, with sharp angles and clean lines. ### 6.0 Predicate Device(s) | 510(k) # | Device | 510(k) Sponsor | 510(k) Clearance Date | |----------|------------------------------------|----------------|-----------------------| | K183274 | RTHawk, HeartVista Cardiac Package | HeartVista | 10/18/2019 | ## 7.0 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 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 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 {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the word "HEARTVISTA" in a stylized, futuristic font. The letters are black, except for a small, cyan-colored dot above the "i". The font is bold and angular, giving the word a modern and technological feel. 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. 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. Additional features are provided to automate and facilitate the set of tasks performed during a typical cardiac exam. 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 anatomy- and indication-specific Protocols (e.g., ischemia evaluation, valvular evaluation, tissue characterization, etc.). Protocols are pre-set by HeartVista, but new protocols can be created and modified by the end user. RTHawk Apps (Applications) are composed 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 (traditional) 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 push-button 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 {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the word "HEARTVISTA" in a stylized, bold, black font. A cyan dot is positioned above the letter "I" in "VISTA". The font is modern and geometric, with sharp angles and clean lines, giving the word a futuristic appearance. The overall design is simple yet eye-catching, with the cyan dot adding a pop of color. - 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. | Safety Parameter | Safety Level | |------------------------------------------|--------------------------| | Magnetic Field strength | 1.5T, 3.0T | | Operating Modes IEC 60601-2-33 (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 | RTHawk operates compatible MR scanners within the safety parameters listed below: ## 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: {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the word "HEARTVISTA" in a stylized, sans-serif font. The letters are black, and there is a small, light blue circle above the "I" in "VISTA". The font is bold and geometric, giving the word a modern and technological feel. The overall impression is clean and professional. Manufacturers: GE Healthcare (GEHC), Siemens Healthineers Field Strength: 1.5T and 3.0T GE Software Versions: 12, 15, 16, 23, 24, 25, 26 Siemens Software Versions: N4/VE; NX/VA ## 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 HeartVista has made general use of the FDA Recognized Consensus Standards listed in the table below, as applicable to device features and components: | Reference # | Title | |----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | ANSI/AAMI ES60601-1:2005/ (R)2012 +A1+C1 +A2 | (Consolidated text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD), Section 14 Programmable Electrical Medical Systems (PEMS) | | IEC 60601-2-33:2010 +AMD1:2013 +AMD2:2015 (Ed 3.2) | Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis (radiology). | | MS1-2008 (R2020) | Determination of Signal-to-Noise Ratio (SNR) in Diagnostic Magnetic Resonance Imaging | | MS3-2008 (R2020) | Determination of Image Uniformity in Diagnostic Magnetic Resonance Images | | MS4-2010 | Acoustic Noise Measurement Procedure for Diagnostic Magnetic Resonance Imaging Devices | | MS8-2016 | Characterization of the Specific Absorption Rate (SAR) for Magnetic Resonance Imaging Systems | {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the word "HEARTVISTA" in a stylized, futuristic font. The letters are black and have a geometric design. There is a small, cyan-colored dot above the letter "I" in "VISTA". The overall design is clean and modern. | NEMA PS3.1 - 3.20 (2016) | Digital Imaging And Communications In Medicine (DICOM) Set. | |--------------------------|------------------------------------------------------------------------| | ISO 14971:2007 (R2010) | Medical Devices - Application Of Risk Management To Medical Devices | Risk management, compliant with ISO 14971:2007 (R2010) 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 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 RTHawk software is comprised of the following functional modules which are also present in the predicate device: - . 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 ef cient processing of raw data to generate MR . images via a exible, pipelined topology - . Scan Control - responsible for the real-time network transfer of controlling orders for APPs, APPs parameters modi cations, 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. {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the word "HEARTVISTA" in a stylized, futuristic font. The letters are black, and there is a small, cyan-colored dot above the "i" in "VISTA". The font is bold and geometric, giving the word a modern and technological feel. - Visualization - implements all aspects of the user interface, including APP selection, controls to modify APP parameters, image display, image analysis, graphical slice prescription, and image review, save, and export. As with the predicate device, RTHawk Apps (Applications) are composed 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, obligue, 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 are substantially unchanged from the predicate device. In this version of the HeartVista Cardiac Package, notable changes include: - Additional compatibility with Siemens Healthineers MRI scanners with software revisions . N4/VE and NX/VA - Additional views and volumes can be automatically prescribed, including horizontal . 3-chamber, vertical 4-chamber, aortic valve, aortic arch, shimming ROI, and 4d flow volume - The ability to automatically register T1 maps, T2 maps, and Time-Course studies ● acquired on the short axis - Coil profile correction can be optionally applied for selected Apps ● - Images may optionally be displayed with a pseudocolor colormap - Default trigger delays are computed based upon patient heart rate and localizer data - A new user interface is provided for viewing and modifying results of the automatic localizer - A new tool is provided to allow creation of a patient report - . For the FB DE SSFP App, new options are provided to disable the inversion preparation and to enable additional spin-echo T2 preparation - . A new Wait App is provided, which performs no imaging but allows automatic scanning to pause until a certain condition is met (e.g., a specified time has elapsed since a specified prior scan) - . A tool is provided to automatically select a mid-septal ROI for determining T1 from short-axis images 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 following compares the modified device, to the predicate device K183274, RTHawk, or HeartVista Cardiac Package: {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows the word "HEARTVISTA" in a stylized, futuristic font. The letters are black, and there is a small cyan dot above the "i" in "VISTA". The font is bold and geometric, with sharp angles and lines. | Attribute | Predicate Device RTHawk 2.5.1, K183274 HeartVista Cardiac Package | Modified Device RTHawk 3.0.0 HeartVista Cardiac Package | |---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 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 | 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: Manufacturers: GE Healthcare (GEHC), Siemens Healthineers Field Strength: 1.5T and 3.0T | HeartVista, Inc. • 2625 Middlefield Road, #710, Palo Alto CA 94306 • www.heartvista.com {11}------------------------------------------------ Image /page/11/Picture/0 description: The image shows the word "HEARTVISTA" in a stylized, futuristic font. The word is all in capital letters and black. There is a small, light blue dot above the letter "i" in "VISTA". | | Scanner Software Versions: 12, 15, 16, 23, 24, 25, 26 | GE Software Versions: 12, 15, 16, 23, 24, 25, 26 Siemens Software Versions: N4/VE; NX/VA | |-------------------------------|-----------------------------------------------------------|---------------------------------------------------------------------------------------------------| | Scanner Compatibility | GE Healthcare | GE Healthcare, Siemens Healthineers | | Magnetic Field Strength(s) | 1.5T, 3.0T | 1.5T, 3.0T | | Shift/Advance Table | No | No | | Imaging Planes | Transverse, Coronal, Sagittal, Oblique, Double Oblique | Transverse, Coronal, Sagittal, Oblique, Double Oblique | | Pulse sequences | | | | | B0 Mapping | B0 Mapping | | | Cardiac Localizer | Cardiac Localizer | | | Cardiac T1 Map | Cardiac T1 Map | | | Cardiac T2 Map | Cardiac T2 Map | | | Cardiac T2* Map Spiral | Cardiac T2* Map Spiral | | | Cardiac T2* Map Cartesian | Cardiac T2* Map Cartesian | | | Cartesian Shimming | Cartesian Shimming | | | Cine Cartesian SSFP | Cine Cartesian SSFP | | | Cine DE Cal | Cine DE Cal | | | Cine Spiral SSFP | Cine Spiral SSFP | | | FB DE GRE Cal | FB DE GRE Cal | | | FB DE GRE | FB DE GRE | | | FB DE SSFP | FB DE SSFP | | | FB MS Tagging GRE | FB MS Tagging GRE | | | FB Multi-Slice GRE | FB Multi-Slice GRE | | | FB Multi-Slice SSFP | FB Multi-Slice SSFP | | | Gated 3D MRA GRE | Gated 3D MRA GRE | | | Gated High-Res GRE | Gated High-Res GRE | | | Gated Double-IR FSE | Gated Double-IR FSE | | | HART GRE | HART GRE | | | HART SSFP | HART SSFP | | | Multi-Slice Cine Flow | Multi-Slice Cine Flow | | | Multi-Slice DE GRE | Multi-Slice DE GRE | | | Multi-Slice DE SSFP | Multi-Slice DE SSFP | | | Nav 3D DE GRE | Nav 3D DE GRE | | | Noise Measurement | Noise Measurement | | | Real-Time Loc GRE | Real-Time Loc GRE | | | Real-Time Loc SSFP | Real-Time Loc SSFP | | | Real-Time Color PC | Real-Time Color PC | | | Single-BH 3D DE GRE | Single-BH 3D DE GRE | | | Stack of Spiral Cine Flow | Stack of Spiral Cine Flow | | | Time Course GRE | Time Course GRE | | | | Wait | | Remote Scanning and Support | Yes | Yes | | Automated Scan Planning | Yes | Yes | {12}------------------------------------------------ Image /page/12/Picture/0 description: The image shows the word "HEARTVISTA" in a stylized, bold, black font. A small, cyan-colored dot is positioned above the letter "I" in "VISTA", serving as a visual accent. The font appears modern and geometric, with sharp angles and clean lines. # 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.