Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes image processing and analysis techniques (volumetry, time intensity plots, mismatch measurement, vessel density) but does not mention AI, ML, or related terms like neural networks or deep learning. The performance studies mention phantom testing, which is typical for traditional image processing validation, not necessarily AI/ML model validation.

Therapeutic

No.
The device is described as an image processing software package and an aid to physician diagnosis, not as a device that directly provides therapy or treatment.

Diagnostic

Yes

Explanation: The device description states that RAPID is software that processes digital images from diagnostic imaging systems "as an aid to physician diagnosis." This directly indicates its role in assisting in the diagnostic process.

SaMD (Software as a Medical Device)

Yes

The device description explicitly states "RAPID is a software-only device consisting of one or more RAPID Servers (dedicated or virtual and an iSchemaView Server)." and reiterates "RAPID is a software-only device designed to streamline medical image processing tasks". While it interacts with hardware (standard computers, virtual platforms, DICOM imaging devices, servers), the device itself, as described, is the software package.

IVD (In Vitro Diagnostic)

Based on the provided information, it is highly likely that this device is an IVD (In Vitro Diagnostic). Here's why:

Intended Use: The intended use explicitly states that the software is used for "image viewing, processing and analysis of images" acquired from diagnostic imaging devices (CT and MRI). It also mentions providing "viewing and analysis capabilities for functional and dynamic imaging datasets" and calculating parameters related to "tissue flow (perfusion) and tissue blood volume." This analysis of medical images to provide information about a patient's condition is a core function of many IVDs.
Device Description: The device description reinforces the intended use by stating that RAPID provides "visualization and study of changes in tissue using digital images captured by diagnostic imaging systems... as an aid to physician diagnosis." It also details the types of analysis performed, such as "volumetry of threshold maps," "time intensity plots," and "measurement of mismatch between labeled volumes," all of which are used to extract diagnostic information from the images.
Functionality: The specific modules described (DWI Module and Dynamic Analysis Module) are designed to analyze specific types of imaging data (diffusion-weighted MRI and dynamic contrast-enhanced imaging) to provide quantitative information about tissue properties (water diffusion, flow, blood volume). This type of quantitative analysis of biological samples (in this case, the patient's tissue as represented by the images) is characteristic of IVDs.
Aid to Physician Diagnosis: The description explicitly states that RAPID is used "as an aid to physician diagnosis." This is a key indicator of an IVD, as IVDs are used to provide information that assists healthcare professionals in making diagnostic decisions.
Predicate Device: The mention of a predicate device (K121447; iSchemaView RAPID) strongly suggests that this device is being submitted for regulatory clearance as a medical device, and given its function, it would likely fall under the IVD classification.

While the term "In Vitro Diagnostic" isn't explicitly used in the provided text, the function and intended use of the device align perfectly with the definition of an IVD. It analyzes data derived from a biological sample (the patient's body, captured as images) to provide information for diagnosis.

Therefore, based on the information provided, it is highly probable that this device is an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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 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.

Product codes (comma separated list FDA assigned to the subject device)

LLZ

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.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

CT (Computed Tomography), MRI (Magnetic Image Resonance), CT Perfusion (CT-P), CT Angiography (CTA), Diffusion Weighted MRI (DWI), dynamic contrast-enhanced imaging data for MRI and CT.

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

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. RAPID is typically installed on a server running within a hospital's network.

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)

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. 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.

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.

K121447

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

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).

Summary

0

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.

1

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

2

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 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-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.

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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3

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 Street
Ste. 101
Redwood City, CA 94063
Official Contact:	Jim Rosa
Phone: (303) 704-3374
Email: rosa@ischemaview.com

Summary Preparation Date: March 18, 2018

Device Name and Classification:

Trade Name:	iSchemaView RAPID
Common Name:	PACS – Picture Archiving Communications
System
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:

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.

4

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 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.

5

Section 5: 510(k) Summary Rev B

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:

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.

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.

6

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

7

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.

8

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 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
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 Angiography, 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. | 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 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.

9

Section 5: 510(k) Summary Rev B

10

Section 5: 510(k) Summary Rev B

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).