(81 days)
Not Found
Yes
The device description mentions "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." While not explicitly stating "AI" or "ML," these automated tasks, particularly "automated myocardial segmentation," strongly suggest the use of advanced algorithms that are characteristic of AI/ML techniques in medical imaging.
No
The device is an accessory to MRI systems intended for acquiring, reconstructing, and displaying images for diagnostic purposes, not for providing therapy. It "may assist in the determination of a diagnosis" but does not perform a therapeutic function.
Yes
Explanation: The RTHawk produces images "When interpreted by a trained physician, these images provide information that may assist in the determination of a diagnosis." This explicitly states its role in assisting diagnosis.
No
While the core of the device is software, the description explicitly states it runs on a "stand-alone linux-based computer workstation, color monitor, keyboard and mouse" which is "sourced by the Customer in conformance with HeartVista-provided specifications, and verified prior to installation." This indicates the device includes specific hardware components that are part of the medical device system, even if sourced separately.
Based on the provided text, RTHawk is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnostic purposes.
- RTHawk's Function: RTHawk is an accessory to MRI systems. It acquires, reconstructs, and displays images of the internal structures and functions of the entire body based on magnetic resonance properties. It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states it produces images that, when interpreted by a trained physician, may assist in the determination of a diagnosis. This is consistent with an imaging device, not an IVD.
- Device Description: The description focuses on software for data acquisition, reconstruction, and display of MR imaging data, not on the analysis of biological samples.
Therefore, RTHawk falls under the category of a medical imaging device accessory, not an In Vitro Diagnostic device.
No
The letter explicitly states "Control Plan Authorized (PCCP) and relevant text: Not Found", indicating that a PCCP was not reviewed or approved for this device.
Intended Use / Indications for Use
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
Product codes (comma separated list FDA assigned to the subject device)
LNH
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 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
- 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance (MR)
Anatomical Site
Entire body, cardiovascular (CMR)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained physician / Clinical setting
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 | |
| 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1000 Magnetic resonance diagnostic device.
(a)
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).(b)
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.
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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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 |