iSchemaView's RAPID is an image processing software package to be used by trained professionals, including but not limited to physicians and medical technicians.

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.

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

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.

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.

RAPID can be installed on a customer's Server or it can be accessed online as 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:

volumetry of threshold 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-only device consisting of one or more RAPID Servers (dedicated or virtual and an iSchemaView Server). The RAPID Server is an image processing engine that connects to a hospital LAN, 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 hospital server. Where available, the RAPID Server is placed logically in the demilitarized zone (DMZ) of the hospital's network to facilitate bidirectional secure connection between the (local) RAPID Server and the centralized iSchemaView Server.

RAPID is a software-only device designed to streamline medical image processing tasks that are time consuming and fatiguing in routine patient workup. RAPID is typically installed on a server running within a hospital's network and operates with minimal user interaction. Once the CT or MR 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 as CT or MRI data, and determine the suitable processing module. RAPID is a toolbox of modules which support various analysis methods used in clinical practice today:

RAPID CTA: used to visualize large cerebral vessels and analyze hemispheric difference . via contralateral comparison.
. RAPID MR DWI Module: used to visualize local water diffusion properties of tissue from the analysis of diffusion-weighted MRI data.
RAPID Dynamic Analysis Module: 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.

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).

AI/ML Overview

Here's an analysis of the acceptance criteria and supporting study for the iSchemaView RAPID device, based on the provided FDA 510(k) summary:

Acceptance Criteria and Device Performance

The provided document describes the iSchemaView RAPID device (K172477) as substantially equivalent to its predicate device (K121447). The acceptance criteria, while not explicitly listed in a detailed quantitative manner, can be inferred from the "Substantial Equivalence Discussion" table and the claims made regarding the device's performance. The primary acceptance criterion is that the new device (K172477) performs at least as well as, and ideally expands upon, the capabilities of the predicate device (K121447) without introducing new safety or effectiveness concerns.

The core performance claims verified through testing are:

Accurate representation of key processing parameters under clinically relevant conditions.
Meeting all design requirements and specifications.
Reliable processing and analysis of CT and MRI medical images for tissue evaluation.
Successful integration of the CTA modality.

Table of Acceptance Criteria and Reported Device Performance

Given the nature of a 510(k) summary for substantial equivalence, the "acceptance criteria" are framed around matching or improving upon the predicate device's capabilities and regulatory compliance.

Acceptance Criterion (Inferred from Substantial Equivalence Claim)	Reported Device Performance (K172477)
Intended Use/Indications for Use: Same as K121447, plus inclusion of CTA modality.	Meets/Exceeds: "iSchemaView's RAPID is an image processing software package to be used by trained professionals... The iSchemaView RAPID provides both viewing and analysis capabilities for functional and dynamic imaging datasets acquired with CT Perfusion, CT Angiography, and MRI including a Diffusion Weighted MRI (DWI) Module and a Dynamic Analysis Module..." The indications are identical to the predicate except for the explicit inclusion of CT Angiography. This is an expansion of functionality.
PACS Functionality: Same basic PACS functions (view, process, analyze, query, list).	Meets: "Performs standard PACS functions with respect to querying and listing." "View, process and analyze medical images." (Same as predicate).
Computer Platform: Standard off-the-shelf PC/server or virtual platform.	Meets: "Standard off-the-shelf PC workstation/server; Virtual platform such as VMware" (Same as predicate).
DICOM Compliance: Yes.	Meets: "Yes" (Same as predicate).
Functional Overview: Software for visualization and study of tissue changes in CT/MRI, providing viewing and quantification.	Meets: "RAPID is a software package that provides for the visualization and study of changes of tissue in digital images captured by CT and MRI. RAPID provides viewing and quantification." (Same as predicate).
Data Acquisition: Acquires medical images from DICOM compliant devices/modalities.	Meets: "Acquires medical image data from DICOM compliant imaging devices and modalities" (Same as predicate).
Data/Image Types: CT and MRI via DICOM.	Meets: "Computed Tomography (CT) via DICOM Format; Magnetic Image Resonance (MRI) via DICOM Format" (Same as predicate).
Acquisition & Modalities Features (MRI): DWI and Dynamic Analysis (perfusion & blood volume).	Meets: "Diffusion Weighted Image (DWI); Dynamic Analysis tissue flow (perfusion) and tissue blood volume" (Same as predicate).
Acquisition & Modalities Features (CT): CT Perfusion (CTP).	Meets/Exceeds: "CT Perfusion (CTP); CTA-large vessel density analysis" (The CTA analysis is new for K172477, whereas K121447 only had CT-P Analysis). This is a key enhancement.
Computed Parameter Maps (Diffusion MRI): isoDWI, ADC, Trace, FA, color FA.	Meets: "Isotropic DWI (isoDWI); ADC; Trace of diffusion tensor (Trace); Fractional Anisotropy (FA) and color FA" (Same as predicate).
Computed Parameter Maps (Perfusion MRI & CT): CBF, CBV, MTT, Tmax.	Meets: "Cerebral blood flow (CBF); Cerebral blood volume (CBV); Mean transit time (MTT); Tissue residue function time to peak (Tmax)" (Same as predicate).
Measurement Tools (MRI and CT): AIF, VOF, Time-course, Mask, ROI, Volumetry, volumetric comparison, motion correction, export files, acquire/transmit/process/store images.	Meets: "Arterial input function (AIF)Venous output function (VOF); Time-course; Mask; Region of interest (ROI) and Volumetry; Volumetric comparison between 2 ROIs; Motion correction; Export perfusion and diffusion files to PACS and DICOM file systems; Acquire, transmit, process, and store medical images" (All listed as similar or identical to predicate).
Reliability and Accuracy: Processes and analyzes images reliably to provide accurate representation of parameters and meet design requirements.	Meets: "...confirms the software reliably processes and supports analysis of CT and MRI medical images for tissue evaluation." "This 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. Software performance, validation and verification testing demonstrated that the RAPID system met all design requirements and specifications."
Safety and Effectiveness: Compliant with 21 CFR, Part 820.30 and EN ISO 14971:2012.	Meets: "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 14971:2012 (risk management)."
No New Safety/Effectiveness Issues: Introduction of new features (e.g., CTA) does not create new safety or effectiveness concerns.	Meets: "The minor differences between the RAPID (K172477) and its predicate (K121447) raise no new issues of safety or effectiveness as demonstrated by the testing conducted with RAPID (K172477) that confirms the software reliably processes and supports analysis of CT and MRI medical images for tissue evaluation."

The study that proves the device meets the acceptance criteria is referred to as "extensive performance validation testing and software verification and validation testing of the RAPID system."

Detailed Information on the Study:

Sample Size used for the test set and the data provenance:
The document does not specify the sample size for the test set or the data provenance (e.g., country of origin, retrospective/prospective nature of the data). It only broadly states "extensive performance validation testing."
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document does not specify the number of experts or their qualifications used to establish ground truth for testing.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
The document does not specify any adjudication method for establishing ground truth or evaluating the test set.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it quantify any effect size of human improvement with AI assistance. The focus is on the software's standalone performance and its comparison to its own predicate device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Yes, a standalone performance evaluation was conducted. The document states:
- "This 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."
- "Performance, validation and verification testing demonstrated that the RAPID system met all design requirements and specifications."
- "The RAPID System performance has been validated through the use of phantoms."
  These statements indicate testing of the algorithm itself.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the "performance validation testing," the document explicitly mentions that "The RAPID System performance has been validated through the use of phantoms." This indicates that, at least in part, the ground truth was established through known physical or digital models with predefined characteristics. It's also implied that the system's output was compared against "key processing parameters" which likely have established normal or pathological ranges, potentially derived from expert knowledge or clinical standards, though this is not explicitly detailed.
The sample size for the training set:
The document does not specify the sample size for the training set. This information is typically not included in a 510(k) summary focused on substantial equivalence.
How the ground truth for the training set was established:
The document does not specify how the ground truth for the training set (if any distinct training set was used separate from the predicate's development) was established. Given the context of a 510(k) for an updated version of an already cleared device, much of the development would likely build upon the established datasets and methodologies from the predicate.

Summary

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Image /page/0/Picture/0 description: The image shows 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

iSchemaView, Inc. % Mr. Jim Rosa VP QA/RA 201 Marshall Street, Suite 101 REDWOOD CITY CA 94063

April 19, 2018

Re: K172477

Trade/Device Name: iSchemaView RAPID Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: March 26, 2018 Received: March 29, 2018

Dear Mr. Rosa:

We have reviewed vour Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael D. O'Hara For

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

Enclosure

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Indications for Use

510(k) Number (if known) K172477

Device Name iSchemaView RAPID

Indications for Use (Describe)

iSchemaView's RAPID is an image processing software package to be used by trained professionals, including but not limited to physicians and medical technicians.

The iSchemaView RAPID provides both viewing and analysis capabilities for functional and dynamic imaging datasets acquired with CT-P), CT Angiography (CTA), and MRI including a Diffusion Weighted MRI (DWI) Module and a Dynamic Analysis Module (dynamic contrast-enhanced imaging data for MRI and CT).

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

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)

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Section 5: 510(k) Summary Rev B

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:	201 Marshall StreetSte. 101Redwood City, CA 94063
Official Contact:	Jim RosaPhone: (303) 704-3374Email: rosa@ischemaview.com

Summary Preparation Date: March 18, 2018

Device Name and Classification:

Trade Name:	iSchemaView RAPID
Common Name:	PACS – Picture Archiving CommunicationsSystem
Classification:	II
Product Code:	LLZ
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 device:

iSchemaView RAPID (K121447)

Previous FDA Submission: iSchemaView RAPID (K121447)

Device Description:

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Section 5: 510(k) Summary Rev B

RAPID can be installed on a customer's Server or it can be accessed online as 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:

volumetry of threshold maps
time intensity plots for dynamic time courses ●
measurement of mismatch between labeled volumes on co-registered image volumes
. large vessel density

RAPID CTA: used to visualize large cerebral vessels and analyze hemispheric difference . via contralateral comparison.
. RAPID MR DWI Module: used to visualize local water diffusion properties of tissue from the analysis of diffusion-weighted MRI data.
RAPID Dynamic Analysis Module: 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.

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Section 5: 510(k) Summary Rev B

Indications for Use:

iSchemaView's RAPID is an image processing software package to be used by trained professionals, including but not limited to physicians and medical technicians.

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

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). RAPID uses a SMTP protocol with security extensions to provide secure emailing.

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.

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Section 5: 510(k) Summary Rev B

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

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

Performance Standards:

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

EN ISO 14971:2012	Application of Risk Management to Medical Devices
IEC 62304:2015	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)

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.

Additionally, iSchemaView conducted extensive performance validation testing and software verification and validation testing of the RAPID system. This 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. 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 14971:2012 (risk management). The RAPID System performance has been validated through the use of phantoms.

Substantial Equivalence:

RAPID(K172477) is as safe and effective as the previously cleared RAPID

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Section 5: 510(k) Summary Rev B

product (K121447). RAPID(K172477) has the same intended use and similar indications, technological characteristics and principles of operation as its predicate device. The minor differences between the RAPID (K172477) and its predicate (K121447) raise no new issues of safety or effectiveness as demonstrated by the testing conducted with RAPID (K172477) that confirms the software reliably processes and supports analysis of CT and MRI medical images for tissue evaluation. Thus, the RAPID (K172477) software is substantially equivalent. The indications for use has been expanded to include the CTA modality which provides additional information to the physician in support of the original intended use.

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Section 5: 510(k) Summary Rev B

Substantial Equivalence Discussion:

Parameter	RAPID (K172477)	RAPID (K121447)
Product Code	LLZ	LLZ
Regulation	21 CFR §892.2050	21 CFR §892.2050
Intended Use/ Indications forUse	iSchemaView's RAPID is an image processing softwarepackage to be used by trained professionals, including butnot limited to physicians and medical technicians. Thesoftware runs on a standard off-the-shelf computer or avirtual platform, such as VMware, and can be used toperform image viewing, processing and analysis of images.Data and images are acquired through DICOM compliantimaging devices.The iSchemaView RAPID provides both viewing andanalysis capabilities for functional and dynamic imagingdatasets acquired with CT Perfusion, CT Angiography, andMRI including a Diffusion Weighted MRI (DWI) Module anda Dynamic Analysis Module (dynamic contrast-enhancedimaging data for MRI and CT).The DWI Module is used to visualize local water diffusionproperties from the analysis of diffusion - weighted MRI data.The Dynamic Analysis Module is used for visualization andanalysis of dynamic imaging data, showing properties ofchanges in contrast over time. This functionality includescalculation of parameters related to tissue flow (perfusion) andtissue blood volume.	iSchemaView's RAPID is an image processing softwarepackage to be used by trained professionals, including butnot limited to physicians and medical technicians. Thesoftware runs on a standard off-the-shelf computer or avirtual platform, such as VMware, and can be used toperform image viewing, processing and analysis of images. Data and images are acquired through DICOM compliant imaging devices.The iSchemaView RAPID provides both viewing and analysis capabilities for functional and dynamic imaging datasets acquired with CT Perfusion and MRI including a Diffusion Weighted MRI (DWI) Module, a Dynamic Analysis Module (dynamic contrast-enhanced imaging data for MRI and CT).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.
PACS Functionality
Basic PACS Functions	View, process and analyze medical images. Performs standardPACS functions with respect to querying and listing.	Same
Computer Platform	Standard off-the-shelf PC workstation/serverVirtual platform such as VMware	Same
DICOM Compliance	Yes	Yes
Functional Overview	RAPID is a software package that provides for thevisualization and study of changes of tissue in digitalimages captured by CT and MRI. RAPID providesviewing and quantification.	Same
Data Acquisition	Acquires medical image data from DICOM compliantimaging devices and modalities	Same
Data/Image Types	Computed Tomography (CT) via DICOM Format	Same
	Magnetic Image Resonance (MRI) via DICOM Format	Same
Acquisition and Modalities Features
MRI	Diffusion Weighted Image (DWI)	Yes
	Dynamic Analysis tissue flow (perfusion) and tissue bloodvolume	Yes
CT	CT Perfusion (CTP)	Yes
	CTA-large vessel density analysis	No only CT-P Analysis
Computed Parameter Maps
Diffusion MRI	Isotropic DWI (isoDWI)	Yes
	ADC	Yes
	Trace of diffusion tensor (Trace)	Yes
	Fractional Anisotropy (FA) and color FA	Yes
Perfusion MRI and Perfusion	Cerebral blood flow (CBF)	Yes
CT	Cerebral blood volume (CBV)	Yes
	Mean transit time (MTT)	Yes
	Tissue residue function time to peak (Tmax)	Yes
Measurement Tools
MRI and CT Tools	Arterial input function (AIF)Venous output function(VOF)	Yes
	Time-course	Yes
	Mask	Yes
	Region of interest (ROI) and Volumetry	Yes
	Volumetric comparison between 2 ROIs	Yes
	Motion correction	Yes
	Export perfusion and diffusion files to PACS andDICOM file systems	Yes
	Acquire, transmit, process, and store medicalimages	Yes

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Section 5: 510(k) Summary Rev B

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Conclusion:

In conclusion, the iSchemaView RAPID (K172477) is substantially equivalent in intended use, technological characteristics, safety, and performance characteristics to the legally marketed predicate device, RAPID (K121447).

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
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.(b)
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).