Rapid

K233582 · Ischemaview, Inc. · LLZ · Apr 22, 2024 · Radiology

Device Facts

• Record ID: K233582
• Device Name: Rapid
• Applicant: Ischemaview, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Apr 22, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

Rapid is an image processing software package to be used by trained professionals, including but not limited to physicians (medical analysis and decision making) and medical technicians (administrative case processing). The software runs on a standard off-the-shelf computer or a virtual platform, such as VMware, and can be used to perform image viewing, processing, and analysis of images are acquired through DICOM compliant imaging devices. Rapid is indicated for use in Adults only. Rapid provides both viewing and analysis capabilities for functional and dynamic imaging datasets acquired with CT, CT Perfusion (CTP), CT Angiography (CTA), C-arm CT Perfusion and MRI including a Diffusion Weighted MRI (DWI) Module and a Dynamic Analysis Module (dynamic contrast-enhanced imaging data for MRI, CT, and C-arm CT). Rapid C-arm CT Perfusion can be used to qualitatively assess cerebral hemodynamics in the angiography suite. The CT analysis includes NCCT maps showing areas of hypodense and hyperdense tissue. The DWI Module is used to visualize local water diffusion properties from the analysis of diffusion - weighted MRI data. The Dynamic Analysis Module is used for visualization and analysis of dynamic imaging data, showing properties of changes in contrast over time. This functionality includes calculation of parameters related to tissue flow (perfusion) and tissue blood volume. Rapid CT Perfusion and Rapid MR Perfusion can be used by physicians to aid in the selection of acute stroke patients (with known occlusion of the intracranial internal carotid artery or proximal middle cerebral artery). Instructions for the use of contrast agents for this indication can be found in Appendix A of the User's Manual. Additional information for safe and effective drug use is available in the product-specific iodinated CT and gadolinium-based MR contrast drug labeling. In addition to the Rapid imaging criteria, patients must meet the clinical requirements for thrombectomy, as assessed by the physician, and have none of the following contraindications or exclusions: Bolus Quality: absent or inadequate bolus. Patient Motion: excessive motion leading to artifacts that make the scan technically inadequate. Presence of hemorrhage. C-Arm CTP is not to be used in the Rapid Thrombectomy indication criteria, other modalities should be consulted.

Device Story

Rapid is a software-based medical image management and processing system (MIMPS) for viewing, quantifying, and analyzing DICOM-compliant CT and MRI datasets. It operates on standard off-the-shelf hardware or virtual platforms (e.g., VMware) within hospital networks. The system processes dynamic contrast-enhanced imaging and diffusion-weighted data to generate perfusion maps (CBF, CBV, MTT, Tmax) and tissue density maps. Physicians use these outputs to assess cerebral hemodynamics and select acute stroke patients for thrombectomy. C-arm CT perfusion is supported for qualitative assessment in the angiography suite. The device automates time-consuming image processing tasks, reducing clinician fatigue. It integrates into existing radiological networks, supporting secure data transfer via VPN/SSH. By providing standardized, quantitative, and qualitative visualization of tissue perfusion and diffusion, the device assists in clinical decision-making, potentially improving patient selection for time-sensitive interventions like thrombectomy.

Clinical Evidence

Bench testing only. Extensive phantom validation testing was conducted to characterize perfusion imaging performance across conventional CT and C-arm CT scanners. Results demonstrated accurate representation of key processing parameters (MTT, Tmax) under clinically relevant conditions. Software verification and validation confirmed adherence to design requirements.

Technological Characteristics

Software-based MIMPS; runs on standard off-the-shelf Linux-based servers or virtualized environments. Supports DICOM protocol for image acquisition/transfer. Connectivity via hospital LAN/WAN using VPN (RFC2401/4301) or SSH. Implements image processing modules for perfusion (CTP/MRP/C-arm CTP), diffusion (DWI), and dynamic analysis. Complies with NEMA PS 3.1-3.20 (DICOM), EN ISO 14971:2019, IEC 62304:2016, IEC 62366:2015, and IEC 81001-5-1.

Indications for Use

Indicated for adult patients requiring image processing for functional and dynamic imaging datasets (CT, CTP, CTA, C-arm CTP, MRI, DWI). Used by physicians to aid in selection of acute stroke patients with known intracranial internal carotid or proximal middle cerebral artery occlusion for thrombectomy. Contraindications: absent/inadequate bolus, excessive patient motion, presence of hemorrhage.

Regulatory Classification

Identification

A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Predicate Devices

• iSchemaView Rapid (K213165)

Submission Summary (Full Text)

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iSchemaView Inc. Jim Rosa SVP Quality and Regulatory 1120 Washington Ave., Ste 200 Golden. Colorado 80401

Re: K233582

April 22, 2024

Trade/Device Name: Rapid Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ, QIH Dated: March 18, 2024 Received: March 19, 2024

Dear Jim Rosa:

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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Jessica Lamb

Jessica Lamb Assistant Director DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

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### Indications for Use

510(k) Number (if known) K233582

Device Name Rapid

#### Indications for Use (Describe)

Rapid is an image processing software package to be used by trained professionals, including but not limited to physicians (medical analysis and decision making) and medical technicians (administrative case processing). The software runs on a standard off-the-shelf computer or a virtual platform, such as VMware, and can be used to perform image viewing, processing, and analysis of images are acquired through DICOM compliant imaging devices. Rapid is indicated for use in Adults only.

Rapid provides both viewing and analysis capabilities for functional and dynamic imaging datasets acquired with CT, CT Perfusion (CTP), CT Angiography (CTA), C-arm CT Perfusion and MRI including a Diffusion Weighted MRI (DWI) Module and a Dynamic Analysis Module (dynamic contrast-enhanced imaging data for MRI, CT, and C-arm CT).

Rapid C-arm CT Perfusion can be used to qualitatively assess cerebral hemodynamics in the angiography suite.

The CT analysis includes NCCT maps showing areas of hypodense and hyperdense tissue.

The DWI Module is used to visualize local water diffusion properties from the analysis of diffusion - weighted MRI data.

The Dynamic Analysis Module is used for visualization and analysis of dynamic imaging data, showing properties of changes in contrast over time. This functionality includes calculation of parameters related to tissue flow (perfusion) and tissue blood volume.

Rapid CT Perfusion and Rapid MR Perfusion can be used by physicians to aid in the selection of acute stroke patients (with known occlusion of the intracranial internal carotid artery or proximal middle cerebral artery). Instructions for the use of contrast agents for this indication can be found in Appendix A of the User's Manual. Additional information for safe and effective drug use is available in the product-specific iodinated CT and gadolinium-based MR contrast drug labeling.

In addition to the Rapid imaging criteria, patients must meet the clinical requirements for thrombectomy, as assessed by the physician, and have none of the following contraindications or exclusions:

· Bolus Quality: absent or inadequate bolus.

· Patient Motion: excessive motion leading to artifacts that make the scan technically inadequate.

· Presence of hemorrhage.

· C-Arm CTP is not to be used in the Rapid Thrombectomy indication criteria, other modalities should be consulted.

#### Cautions:

· C-Arm CTP provides qualitative data only, review other modalities prior to diagnosis. CBV and CBT are not absolute and CBT, CBV, MTT and Tmax are supported for qualitative interpretation of the perfusion maps only.

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.

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iSchemaView - Traditional 510(k) Rapid Section 11: 510(k) Summary

# 510(k) Summary

## iSchemaView, Inc.'s Rapid

This document contains the 510(k) summary for the iSchemaView Rapid. The content of this summary is based on the requirements of 21 CFR Section 807.92(c).

#### Applicant Name and Address:

| Name: | iSchemaView, Inc. |
|-------------------|----------------------------------------------------------------|
| Address: | 1120 Washington St., Suite 200<br>Golden, CO 80401 |
| Official Contact: | Jim Rosa<br>Phone: [phone]<br>Email: [e-mail] |

#### Device Name and Classification:

| Trade Name: | Rapid |
|-----------------------|---------------------------------------------------------|
| Common Name: | MIMPS – Medical image management and processing system. |
| Classification: | II |
| Product Code: | Primary: LLZ, Secondary: QIH |
| Regulation No: | 21 C.F.R. §892.2050 |
| Classification Panel: | Radiology Devices |

#### Predicate Devices:

The iSchemaView Rapid is claimed to be substantially equivalent to the following legally marketed predicate devices:

Primary: iSchemaView Rapid (K213165).

#### Previous Related FDA Submission:

- iSchemaView Rapid (K121447) iSchemaView Rapid (K172477) iSchemaView Rapid (K182130) iSchemaView Rapid (K213165) iSchemaView Rapid (K233512)
#### Device Description:

Rapid is a software package that provides for the visualization and study of changes in tissue using digital images captured by diagnostic imaging systems including CT (Computed Tomography) and MRI (Magnetic Image Resonance), as an aid to physician diagnosis.

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Section 11: 510(k) Summary

Rapid can be installed on a customer's Server or it can be accessed online as a virtual system. It provides viewing, quantification, analysis and reporting capabilities.

Rapid works with the following types of (DICOM compliant) medical image data:

- CT (Computed Tomography)
- MRI(Magnetic Image Resonance) ●

Rapid acquires (DICOM compliant) medical image data from the following sources:

- . DICOM file
- DICOM CD-R ●
- Network using DICOM protocol. ●

Rapid provides tools for performing the following types of analysis:

- selection of acute stroke patients for endovascular thrombectomy ●
- volumetry of thresholded maps
- time intensity plots for dynamic time courses
- measurement of mismatch between labeled volumes on co-registered image ● volumes
- large vessel density. ●

Rapid is a Software as a Medical Device (SaMD) consisting of one or more Rapid Servers (dedicated or virtual). The Rapid Server is an image processing engine that connects to a hospital LAN, or inside the Hospital Firewall. It can be a dedicated Rapid Server or a VM Rapid appliance, which is a virtualized Rapid Server that runs on a dedicated server.

Rapid is designed to streamline medical image processing tasks that are time consuming and fatiguing in routine patient workup. Once Rapid is installed it operates with minimal user interaction. Once the CT [NCCT, CT, CTA, C-arm CT(CBCT)] or MR (MR, MRA) data are acquired, the CT or MRI console operator selects Rapid as the target for the DICOM images, and then the operator selects which study/series data to be sent to Rapid. Based on the type of incoming DICOM data, Rapid will identify the data set scanning modality and determine the suitable processing module. The Rapid Platform is a central unit which coordinates the execution image processing modules which support various analysis methods used in clinical practice today:

- Rapid CTP/MRP/C-arm CTP, DWI, Dynamic Analysis (Original: K121447, Updated ● with K172477, K182130, K213165, K233512 and K233582)
- Rapid CTA (K172477) ●
- Rapid ASPECTS (K200760, K232156)
- Rapid ICH (K193087, K221456)
- Rapid LVO (K200941, K221248)
- Rapid NCCT Stroke (K222884)
- . Rapid RV/LV (K223396)
- Rapid PETN (K220499)
- Rapid ANRTN (K230074) ●
- Rapid SDH (K232436) ●

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Section 11: 510(k) Summary

The iSchemaView Server is a dedicated server that provides a central repository for Rapid data. All iSchemaView Server data is stored on encrypted hard disks. It also provides a user interface for accessing Rapid data. It connects to a firewalled Data Center Network and has its own firewall for additional cyber/data security. The iSchemaView Server connects to one or more Rapid Servers via WAN. Available types of connection include VPN (Virtual Private Network - RFC2401 and RFC4301 Standards) Tunnel and SSH (Secure Shell).

### Indications for Use

Rapid is an image processing software package to be used by trained professionals, including but not limited to physicians (medical analysis and decision making) and medical technicians (administrative case processing). The software runs on a standard off-the-shelf computer or a virtual platform, such as VMware, and can be used to perform image viewing, processing, and analysis of images. Data and images are acquired through DICOM compliant imaging devices. Rapid is indicated for use in Adults only.

Rapid provides both viewing and analysis capabilities for functional and dynamic imaging datasets acquired with CT, CT Perfusion (CTP), CT Angiography (CTA), C-arm CT Perfusion and MRI including a Diffusion Weighted MRI (DWI) Module and a Dynamic Analysis Module (dynamic contrast-enhanced imaging data for MRI, CT, and C-arm CT).

Rapid C-arm CT Perfusion can be used to qualitatively assess cerebral hemodynamics in the angiography suite.

The CT analysis includes NCCT maps showing areas of hypodense and hyperdense tissue.

The DWI Module is used to visualize local water diffusion properties from the analysis of diffusion - weighted MRI data.

The Dynamic Analysis Module is used for visualization and analysis of dynamic imaging data, showing properties of changes in contrast over time. This functionality includes calculation of parameters related to tissue flow (perfusion) and tissue blood volume.

Rapid CT Perfusion and Rapid MR Perfusion can be used by physicians to aid in the selection of acute stroke patients (with known occlusion of the intracranial internal carotid artery or proximal middle cerebral artery). Instructions for the use of contrast agents for this indication can be found in Appendix A of the User's Manual. Additional information for safe and effective drug use is available in the product-specific iodinated CT and gadolinium-based MR contrast drug labeling.

In addition to the Rapid imaging criteria, patients must meet the clinical requirements for thrombectomy, as assessed by the physician, and have none of the following contraindications or exclusions:

- Bolus Quality: absent or inadequate bolus. ●
- Patient Motion: excessive motion leading to artifacts that make the scan technically . inadequate.
- Presence of hemorrhage. ●

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#### Section 11: 510(k) Summary

- C-Arm CTP is not to be used in the Rapid Thrombectomy indication for patient selection ● criteria, other modalities should be consulted.
#### Caution:

- . C-Arm CTP provides qualitative data only, review other modalities prior to diagnosis. CBV and CBT are not absolute and CBT, CBV, MTT and Tmax are supported for qualitative interpretation of the perfusion maps only.
#### Technological Characteristics:

Rapid performs the following functions:

- processes DICOM images from multiple sources to provide visualization of changes . of tissue perfusion, diffusion and change.
- receives DICOM images from external DICOM image providers (modalities (CT/MRI . Scanners), PACS and Workstations) and sends DICOM images to external image consumers.
- processes requests, statuses and results, and references therein, which are stored in a ● searchable database.
- processing status is available through a web browser using HTTP, HTML and PHP. ●
- can send summary results to the user over email. For this, Rapid generally connects to the infrastructure of the medical partner (e.g., the hospital). In particular, Rapid uses a SMTP protocol with security extensions to provide secure communications.

Rapid is available in the following configurations:

- . Standard Rapid, which is installed directly on a customer's Linux-based server and integrated with medical image processing software such as commercial PACS.
- . Virtual Rapid, wherein the user accesses Rapid online and uses it to process DICOM images otherwise available on his/her computer or in the cloud.

Rapid is a DICOM-compliant PACS software that provides comprehensive functionality to transfer, process, and display modality specific imaging data. Rapid runs on standard "off-theshelf computer and networking hardware. Rapid is entirely independent from CT, MRI, or independent PACS platforms. It supports secure VPN (Virtual Private Network) networking or encapsulated Secure Shell (SSH), and seamlessly integrates into an existing radiological data network.

#### Clinical Characteristics:

The primary users of Rapid software are medical imaging professionals who analyze tissue using conventional and C-arm CT or MRI images generated by Rapid provide additional diagnostic information, which is derived from the temporal/diffusion/density features of the native CT or MRI images.

Rapid CT Perfusion and Rapid MRI can be used by physicians to select acute stroke patients for endovascular thrombectomy. The recommended selection criteria are listed in the table below. Patients must meet the clinical requirements for thrombectomy as assessed by the

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Section 11: 510(k) Summary

physician. Rapid C-arm CT Perfusion can be used to assess cerebral hemodynamics in the angiography suite.

### Performance Standards:

Rapid has been developed in conformance with the following standards, as applicable:

| EN ISO 14971:2019 | Application of Risk Management to Medical Devices |
|--------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| IEC 62304:2016 | Medical device software – Software lifecycle processes |
| IEC 62366:2015 | Application of Usability Engineering to Medical Devices |
| NEMA PS 3.1 - 3.20 | Digital Imaging and Communications in Medicine (DICOM) |
| IEC 81001-5-1 | Health software and health IT systems safety, effectiveness and<br>security -Part 5-1: Security - Activities in the product life cycle |

#### Performance Data:

Rapid complies with DICOM (Digital Imaging and Communications in Medicine) - Developed by the American College of Radiology and the National Electrical Manufacturers Association. NEMA PS 3.1 - 3.20.

iSchemaView conducted extensive phantom validation testing of the Rapid System for characterizing the perfusion imaging performance of conventional CT and C-arm CT scanners. The performance validation testing demonstrated that the Rapid system provides accurate representation of key processing parameters under a range of clinically relevant parameters and perturbations associated with the intended use of the software.

Additionally, iSchemaView conducted software verification and validation testing of the Rapid system. Software performance, validation and verification testing demonstrated that the Rapid system met all design requirements and specifications.

#### Prescriptive Statement:

Caution: Federal law restricts this device to sale by or on the order of a physician.

### Safety & Effectiveness:

Rapid has been designed, verified and validated in compliance with 21 CFR. Part 820.30 requirements. The device has been designed to meet the requirements associated with EN ISO 14971:2019 (risk management). The Rapid System performance has been validated through the use of phantoms and case data.

#### Substantial Equivalence:

The subject device, Rapid System, provides a new claim based on the comprehensive phantom validation study for the use of C-arm CT scanners in the perfusion indication as a qualitative tool to aid the physician in the angiography suite.

Table 1 below summarizes and compares data on the predicate and subject Rapid Systems. The principles of operation of the subject device are the same as those of the predicate device. There are no changes to the predicate Rapid System implementations that change the previously

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Section 11: 510(k) Summary

cleared features. The only difference between the subject and predicate Rapid Systems is the addition of C-arm CT scanners for the perfusion indication of Rapid Core.

Phantom validation results between conventional CT and C-arm CT scanners for the perfusion indication of Rapid Core are comparable with small biases in MTT (mean transit time) and Tmax (time to the maximum of the residue function) which were expected due to the temporal resolution difference in conventional and C-arm CT scanners.

The Rapid System does not raise new questions of safety or effectiveness compared to the predicate Rapid System (K213165) which does not include C-arm CT for perfusion imaging. Therefore, the Rapid is substantially equivalent with respect to the intended use, technological characteristics, and performance characteristics to the legally marketed predicate device, Rapid (K213165), from iSchemaView, Inc.

#### Cybersecurity:

Rapid has been designed and validated to the FDA Cybersecurity Guidance and IEC 81001-5-1.

#### Conclusion:

In conclusion, the iSchemaView Rapid is substantially equivalent in intended use, technological characteristics, safety, and performance characteristics to the legally marketed predicate device, Rapid (K213165).

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Section 11: 510(k) Summary

| Parameter | Rapid (K213165) – Primary Predicate | Rapid – Subject Device |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | LLZ, QIH | LLZ, QIH |
| Regulation | 21 CFR §892.2050 | 21 CFR §892.2050 |
| Intended Use/<br>Indications for<br>Use | Rapid is an image processing software package to be used<br>by trained professionals, including but not limited to<br>physicians and medical technicians. The software runs on<br>a standard off-the-shelf computer or a virtual platform,<br>such as VMware, and can be used to perform image<br>viewing, processing and analysis of images. Data and<br>images are acquired through DICOM compliant imaging<br>devices.<br>Rapid provides both viewing and analysis capabilities for<br>functional and dynamic imaging datasets acquired with CT<br>Perfusion (CTP), CT Angiography (CTA), and MRI<br>including a Diffusion Weighted MRI (DWI) Module and a<br>Dynamic Analysis Module (dynamic contrast-enhanced<br>imaging data for MRI and CT).<br>The CT analysis includes NCCT maps showing areas of<br>hypodense and hyperdense tissue.<br>The DWI Module is used to visualize local water diffusion<br>properties from the analysis of diffusion - weighted MRI<br>data.<br>The Dynamic Analysis Module is used for visualization<br>and analysis of dynamic imaging data, showing properties<br>of changes in contrast over time. This functionality<br>includes calculation of parameters related to tissue flow<br>(perfusion) and tissue blood volume.<br>Rapid CT-Perfusion and Rapid MR-Perfusion can be used by<br>physicians to aid in the selection of acute stroke patients (with<br>known occlusion of the intracranial internal carotid artery or<br>proximal middle cerebral artery) | Rapid is an image processing software package to be used<br>by trained professionals, including but not limited to<br>physicians (medical analysis and decision making) and<br>medical technicians (administrative case processing). The<br>software runs on a standard off-the-shelf computer or a<br>virtual platform, such as VMware, and can be used to<br>perform image viewing, processing, and analysis of<br>images. Data and images are acquired through DICOM<br>compliant imaging devices. Rapid is indicated for Adults<br>only.<br>Rapid provides both viewing and analysis capabilities for<br>functional and dynamic imaging datasets acquired with<br>CT, CT Perfusion (CTP), CT Angiography (CTA), C-arm<br>CT Perfusion and MRI including a Diffusion Weighted<br>MRI (DWI) Module and a Dynamic Analysis Module<br>(dynamic contrast-enhanced imaging data for MRI,<br>CT, and C-arm CT).<br>Rapid C-arm CT Perfusion can be used to qualitatively<br>assess cerebral hemodynamics in the angiography suite.<br>The CT analysis includes NCCT maps showing areas of<br>hypodense and hyperdense tissue.<br>The DWI Module is used to visualize local water<br>diffusion properties from the analysis of diffusion -<br>weighted MRI data.<br>The Dynamic Analysis Module is used for visualization and analysis of dynamic imaging data, showing properties of changes in contrast over time. This functionality includes calculation of parameters related to tissue flow |
| | Instructions for the use of contrast agents for this indication | (perfusion) and tissue blood volume. |
| | Instructions for the use of contrast agents for this indication<br>can be found in Appendix A of the User's Manual.<br>Additional information for safe and effective drug use is<br>available in the product-specific iodinated CT and<br>gadolinium-based MR contrast drug labeling.<br><br>In addition to the Rapid imaging criteria, patients must meet<br>the clinical requirements for thrombectomy, as assessed by<br>the physician, and have none of the following<br>contraindications or exclusions:<br>Bolus Quality: absent or inadequate bolus. Patient Motion: excessive motion leading to artifacts that<br>make the scan technically inadequate. Presence of hemorrhage. | Rapid CT Perfusion and Rapid MR Perfusion can be used<br>by physicians to aid in the selection of acute stroke<br>patients (with known occlusion of the intracranial internal<br>carotid artery or proximal middle cerebral artery).<br><br>Instructions for the use of contrast agents for this<br>indication can be found in Appendix A of the User's<br>Manual. Additional information for safe and effective<br>drug use is available in the product-specific iodinated CT<br>and gadolinium-based MR contrast drug labeling.<br><br>In addition to the Rapid imaging criteria, patients must<br>meet the clinical requirements for thrombectomy, as<br>assessed by the physician, and have none of the following<br>contraindications or exclusions:<br>Bolus Quality: absent or inadequate bolus. Patient Motion: excessive motion leading to artifacts<br>that make the scan technically inadequate. Presence of hemorrhage. C-Arm CTP is not used in the Rapid Thrombectomy<br>indication for patient selection criteria, other<br>modalities should be consulted. Caution<br>CBV and CBT are not absolute and CBT, CBV, MTT and<br>Tmax are supported for qualitative interpretation of the<br>perfusion maps only. |
| Basic PACS<br>Functions | Software package which interfaces to a PACS or allows<br>viewing within the application | Same |
| Computer<br>Platform | Standard off-the-shelf Hardware: On-Premises | Standard off-the-shelf Hardware: On-Premises or Cloud<br>Hybrid |
| Software | Mixed Traditional and AI/ML | Same |
| DICOM<br>Compliance | Yes | Same |
| Functional | Rapid is a software package that provides for the<br>visualization and study of changes of tissue in digital<br>images captured by CT and MRI. Rapid provides viewing<br>and quantification. | Rapid is a software package that provides for the<br>visualization and study of changes of tissue in digital<br>images captured by CT and MRI. Rapid provides<br>viewing and quantification. C-Arm CT is for<br>qualitative assessment only. |
| Data/Image<br>Types | Computed Tomography (CT) via DICOM Format<br>C-Arm CT via DICOM Format (not supported in<br>predicate)<br>Magnetic Image Resonance (MRI) via DICOM Format | Supported<br>Qualitative Imaging<br>Supported |
| MRI | Diffusion Weighted Image (DWI)<br>Dynamic Analysis tissue flow (perfusion) and tissue blood<br>volume | Supported<br>Supported |
| CT | CT Perfusion (CTP)<br>CTA-large vessel density analysis | Supported<br>Supported |
| C-arm CT | C-arm CT Perfusion (C-arm CTP) – Not Supported | Supported via qualitative analysis |
| Diffusion MRI | Isotropic DWI (isoDWI)<br>ADC<br>Trace of diffusion tensor (Trace)<br>Fractional Anisotropy (FA) and color FA | Supported<br>Supported<br>Supported<br>Supported |
| Perfusion MRI<br>and Perfusion<br>CT | Cerebral blood flow (CBF)<br>Cerebral blood volume (CBV)<br>Mean transit time (MTT)<br>Tissue residue function time to peak (Tmax) | Supported<br>Supported<br>Supported<br>Supported |
| Perfusion C-<br>arm CT | CBF - Not Supported<br>CBV – Not Supported<br>MTT – Not Supported<br>Tmax – Not Supported | Supported via qualitative analysis<br>Supported via qualitative analysis<br>Supported via qualitative analysis<br>Supported via qualitative analysis…