K Number
K203058
Device Name
CloudVue
Date Cleared
2020-10-29

(21 days)

Product Code
Regulation Number
892.2050
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
CloudVue is a software application that displays medical image data to aid in diagnosis for healthcare professionals. It performs operations relating to the transfer, storage, display, and measurement of image data. CloudVue allows users to perform image manipulations, including window/level, rotation, measurement and markup. CloudVue provides 2D display, Multi-Planar Reformatting and 3D visualization of medical image data, and mobile access to images. CloudVue displays both lossless and lossy compressed images. For lossy images, the medical professional user must determine if the level of loss is acceptable for their purposes. Display monitors or mobile devices used for reading medical images for diagnostic purposes must comply with applicable regulatory approvals and with quality control requirements for their use and maintenance. For mobile diagnostic usage only when a full workstation is not available. Usage for mammography is for reference and referral only.
Device Description
CloudVue is a software application that allows for the display of medical image data within a web browser without installing client software. Conceptually, the application comprises two components: the web viewer and the web server. The server is installed on any computer that meets the minimum system requirements and is configured to communicate with a DICOM archive. The server is capable of DICOM and DICOMweb communication, which allows the connected DICOM archive to exist on a physical server or in the cloud, giving institutions the flexibility to choose a system infrastructure that is best suited to their needs. CloudVue provides fast and secure access to full-fidelity CR, CT, DX, HC, IVUS, MR, NM, OP, OPT, OT, PT, SC, US, and XA images using Chrome, Safari, Firefox, or Edge web browsers. With interactive features, such as: multi-study viewing, multi-monitor support, customized screen and tool layouts, annotation saving and loading, measurement drawing and calibration, reference lines, key images, multi-planar reformatting (MPR), MIP, VR rendering, and image link sharing, CloudVue is a feature-rich solution that informs diagnostic decision-making by healthcare professionals. CloudVue also supports these same features across the following devices: Windows 10 and higher, macOS X and higher, iPad Pro 200 generation and higher, and higher. This level of portability allows healthcare professionals to access their medical image data anytime, anywhere. The display is not part of the subject device, CloudVue, however, is an essential component of a fullyfunctional imaging system. The end user will view the medical images on the display monitor of their choice.
More Information

Not Found

No
The summary describes a medical image viewer with standard image manipulation and display features. There is no mention of AI, ML, or any functionality that would typically involve these technologies for analysis or interpretation.

No.
The device is a software application for displaying and manipulating medical image data to aid in diagnosis, not directly treat or prevent a disease or condition.

Yes

The "Intended Use / Indications for Use" states that CloudVue "displays medical image data to aid in diagnosis for healthcare professionals." Additionally, the "Device Description" mentions that CloudVue is a "feature-rich solution that informs diagnostic decision-making by healthcare professionals." These statements clearly indicate its role in the diagnostic process.

Yes

The device is described as a software application that displays and manipulates medical image data. While it relies on external hardware (computers, mobile devices, displays) for its function, the device itself is solely the software component. The description explicitly states "The display is not part of the subject device, CloudVue".

Based on the provided information, CloudVue is not an In Vitro Diagnostic (IVD) device.

Here's why:

  • IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This includes tests for diagnosis, monitoring, screening, and prognosis.
  • CloudVue's Function: CloudVue is a software application that displays and manipulates medical image data (like X-rays, CT scans, MRIs). It works with images generated by other medical devices, not with specimens taken from the body.
  • Intended Use: The intended use clearly states that CloudVue "displays medical image data to aid in diagnosis for healthcare professionals." This is consistent with a medical image viewer, not an IVD.

Therefore, CloudVue falls under the category of a medical image management and display software, not an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

CloudVue is a software application that displays medical image data to aid in diagnosis for healthcare professionals. It performs operations relating to the transfer, storage, display, and measurement of image data.

CloudVue allows users to perform image manipulations, including window/level, rotation, measurement and markup.

CloudVue provides 2D display, Multi-Planar Reformatting and 3D visualization of medical image data, and mobile access to images.

CloudVue displays both lossy compressed images. For lossy images, the medical professional user must determine if the level of loss is acceptable for their purposes. Display monitors or mobile devices used for reading medical images for diagnostic purposes must comply with applicable regulatory approvals and with quality control requirements for their use and maintenance. For mobile diagnostic usage only when a full workstation is not available.

Usage for mammography is for reference and referral only.

Product codes

LLZ

Device Description

CloudVue is a software application that allows for the display of medical image data within a web browser without installing client software. Conceptually, the application comprises two components: the web viewer and the web server. The server is installed on any computer that meets the minimum system requirements and is configured to communicate with a DICOM archive. The server is capable of DICOM and DICOMweb communication, which allows the connected DICOM archive to exist on a physical server or in the cloud, giving institutions the flexibility to choose a system infrastructure that is best suited to their needs.

CloudVue provides fast and secure access to full-fidelity CR, CT, DX, HC, IVUS, MR, NM, OP, OPT, OT, PT, SC, US, and XA images using Chrome, Safari, Firefox, or Edge web browsers. With interactive features, such as: multi-study viewing, multi-monitor support, customized screen and tool layouts, annotation saving and loading, measurement drawing and calibration, reference lines, key images, multi-planar reformatting (MPR), MIP, VR rendering, and image link sharing, CloudVue is a feature-rich solution that informs diagnostic decision-making by healthcare professionals.

CloudVue also supports these same features across the following devices: Windows 10 and higher, macOS X and higher, iPad Pro 200 generation and higher, and higher. This level of portability allows healthcare professionals to access their medical image data anytime, anywhere.

The display is not part of the subject device, CloudVue, however, is an essential component of a fullyfunctional imaging system. The end user will view the medical images on the display monitor of their choice.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

CR, CT, DX, HC, IVUS, MR, NM, OP, OPT, OT, PT, SC, US, XA

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

healthcare professionals

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)

No clinical testing was required to support safety and effectiveness of the subject device.
Verification and validation activities, driven by risk analysis guided by ISO 14971:2007, were conducted and documentation was provided. These activities included unit testing, integration testing, system testing, and benchmark testing. The recommended portable display devices were all tested for image quality and found to be adequate. All testing activities demonstrated that the device met all design requirements and intended use, and that it is both safe and effective.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K172490

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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).

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October 29, 2020

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".

International Medical Solutions, Inc. % Mr. Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k SAINT PAUL MN 55114

Re: K203058

Trade/Device Name: CloudVue Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: October 7, 2020 Received: October 8, 2020

Dear Mr. Bom:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/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.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

1

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

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K203058

Device Name CloudVue

Indications for Use (Describe)

CloudVue is a software application that displays medical image data to aid in diagnosis for healthcare professionals. It performs operations relating to the transfer, storage, display, and measurement of image data.

CloudVue allows users to perform image manipulations, including window/level, rotation, measurement and markup.

CloudVue provides 2D display, Multi-Planar Reformatting and 3D visualization of medical image data, and mobile access to images.

CloudVue displays both lossy compressed images. For lossy images, the medical professional user must determine if the level of loss is acceptable for their purposes. Display monitors or mobile devices used for reading medical images for diagnostic purposes must comply with applicable regulatory approvals and with quality control requirements for their use and maintenance. For mobile diagnostic usage only when a full workstation is not available.

Usage for mammography is for reference and referral 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)

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Image /page/3/Picture/1 description: The image shows the logo for IMS. The logo consists of a circular design made of three interwoven bands on the left. To the right of the design is the text "IMS" in a bold, dark blue font. Below "IMS" is the tagline "The Power of Partnering" in a smaller, reddish-brown font.

IMS CloudVue 510(k) Summary

K203058

a. Submitter

International Medical Solutions Inc. 2425 Matheson Blvd E Suite 800 Mississauga, ON, L4W 5K4 Canada

Phone: 1-949-232-9298 Email: vcolaco@imstsvc.com

Contact Person: Vernon Colaço, General Manager Date Prepared: August 27, 2020 Submission Date: September 2, 2020

b. Device

Subject Device Information
Device Trade NameCloudVue
Device Common NameMedical Image Processing Software
Classification NamePicture Archiving and Communications System
510(k) NumberK203058
Product CodeLLZ
Device ClassClass II
Regulation Number21 CFR 892.2050
Device PanelRadiology

c. Predicate Device

Predicate Device Information
Device Trade NameeUnity
ManufacturerClient Outlook Inc.
510(k) NumberK172490

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Image /page/4/Picture/1 description: The image shows the logo for IMS. The logo consists of a circular design on the left and the text "IMS" on the right. Below the text "IMS" is the tagline "The Power of Partnering."

The predicate device has not been subject to a design-related recall.

d. Device Description

CloudVue is a software application that allows for the display of medical image data within a web browser without installing client software. Conceptually, the application comprises two components: the web viewer and the web server. The server is installed on any computer that meets the minimum system requirements and is configured to communicate with a DICOM archive. The server is capable of DICOM and DICOMweb communication, which allows the connected DICOM archive to exist on a physical server or in the cloud, giving institutions the flexibility to choose a system infrastructure that is best suited to their needs.

CloudVue provides fast and secure access to full-fidelity CR, CT, DX, HC, IVUS, MR, NM, OP, OPT, OT, PT, SC, US, and XA images using Chrome, Safari, Firefox, or Edge web browsers. With interactive features, such as: multi-study viewing, multi-monitor support, customized screen and tool layouts, annotation saving and loading, measurement drawing and calibration, reference lines, key images, multi-planar reformatting (MPR), MIP, VR rendering, and image link sharing, CloudVue is a feature-rich solution that informs diagnostic decision-making by healthcare professionals.

CloudVue also supports these same features across the following devices: Windows 10 and higher, macOS X and higher, iPad Pro 200 generation and higher, and higher. This level of portability allows healthcare professionals to access their medical image data anytime, anywhere.

The display is not part of the subject device, CloudVue, however, is an essential component of a fullyfunctional imaging system. The end user will view the medical images on the display monitor of their choice.

e. Indications for Use

CloudVue is a software application that displays medical image data to aid in diagnosis for healthcare professionals. It performs operations relating to the transfer, storage, display, and measurement of image data.

CloudVue allows users to perform image manipulations, including window/level, rotation, measurement and markup.

CloudVue provides 2D display, Multi-Planar Reformatting and 3D visualization of medical image data, and mobile access to images.

CloudVue displays both lossless and lossy compressed images, the medical professional user must determine if the level of loss is acceptable for their purposes. Display monitors or mobile devices used for reading medical images for diagnostic purposes must comply with applicable regulatory approvals and with quality control requirements for their use and maintenance. For mobile diagnostic usage only when a full workstation is not available.

Usage for mammography is for reference and referral only.

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f. Comparison of Technological Characteristics with the Predicate Device

CharacteristicIMS CloudVueClient Outlook eUnity
510(k) NumberK203058K172490
Regulatory ClassClass IIClass II
Subject to Device RecallNoNo
Intended UseCloudVue is a software application that
displays medical image data to aid in
diagnosis for healthcare professionals. It
performs operations relating to the
transfer, storage, display, and
measurement of image data.
CloudVue allows users to perform image
manipulations, including window/level,
rotation, measurement and markup.eUnity is a software application that
displays medical image data and
associated clinical reports to aid in
diagnosis for healthcare professionals. It
performs operations relating to the
transfer, storage, display, and
measurement of image data.
eUnity allows users to perform image
manipulations, including window/level,
rotation, measurement and markup.
Indications for UseCloudVue provides 2D display, Multi-
Planar Reformatting and 3D visualization
of medical image data, and mobile
access to images.
CloudVue displays both lossless and
lossy compressed images. For lossy
images, the medical professional user
must determine if the level of loss is
acceptable for their purposes. Display
monitors or mobile devices used for
reading medical images for diagnostic
purposes must comply with applicable
regulatory approvals and with quality
control requirements for their use and
maintenance. For mobile diagnostic
usage only when a full workstation is not
available.
Usage for mammography is for
reference and referral only.eUnity provides 2D display, Multi-Planar
Reformatting and 3D visualization of
medical image data, and mobile access
to images.
eUnity displays both lossless and lossy
compressed images. For lossy images,
the medical professional user must
determine if the level of loss is
acceptable for their purposes. Display
monitors or mobile devices used for
reading medical images for diagnostic
purposes must comply with applicable
regulatory approvals and with quality
control requirements for their use and
maintenance. For Mobile diagnostic
usage only when a full workstation is not
available.
Mobile usage for mammography is for
reference and referral only.
User Installation RequirementsThin client - no install; runs within
browserThin client - no install; runs within
browser
CommunicationsDICOM, Non-DICOMDICOM, Non-DICOM, IHE
ModalitiesCR, CT, DX, HC, IVUS, MR, NM, OP, OPT,
OT, PT, SC, US, XACR, CT, DX, MR, PT, SC, US, XA, ECG, MG,
NM, OP, PR, RF, SR, VL
Tools
Window
Level/Rotate/Pan/Zoom/Reset,
Presets, Invert, Revert to Original,
Image Flip, Image RotateYesYes
Multi-Study Viewing, Image Export,
Image SharingYesYes
Metadata Display/HideYesYes
Orientation Labels, Keyboard
ShortcutsYesYes
Measurements, AnnotationsYesYes
Full-Screen Mode, Multi-Monitor,
LayoutsYesYes
Linking Series, Image Scrolling, Linked
Scrolling, Reference LinesYesYes
Grayscale Softcopy Presentation
States (GSPS)YesYes
Key ImagesYesYes
Magnification LensYesYes
MPR/MIP/3D Features
Multi-Planar Reformat (MPR)YesYes
Oblique and Double Oblique
ReformattingYesYes
Maximum Intensity Projection (MIP)YesYes
Volume Rendering (VR)YesYes
Opacity PresetsYesYes
Scalpel Tool, Bone RemovalNoYes
Mobile-Specific Features
Mobile Luminance CheckYesYes
sSecurity
Data EncryptionHTTPSHTTPS
Data SecurityStored on serverStored on server
Access ControlBuilt-in access control or parent
application access controlBuilt-in access control or parent
application access control

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Image /page/6/Picture/0 description: The image is a logo for IMS. The logo consists of a circular design on the left and the text "IMS The Power of Partnering" on the right. The circular design is made up of three curved shapes that intersect in the center. The text "IMS" is in a bold, sans-serif font, and the text "The Power of Partnering" is in a smaller, serif font.

g. Clinical Performance Data

No clinical testing was required to support safety and effectiveness of the subject device.

h. Summary of Testing

Verification and validation activities, driven by risk analysis guided by ISO 14971:2007, were conducted and documentation was provided. These activities included unit testing, integration testing, system testing, and benchmark testing. The recommended portable display devices were all tested for image quality and found to be adequate. All testing activities demonstrated that the device met all design requirements and intended use, and that it is both safe and effective.

i. Conclusion

In summary, the predicate device is medical image processing software that provides its users with the tools to display and manipulate medical DICOM images without altering the original image itself. The

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Image /page/7/Picture/1 description: The image shows the logo for IMS. The logo consists of a circular design on the left and the text "IMS" on the right. Below the text "IMS" is the tagline "The Power of Partnering".

predicate device is a zero-footprint, software-only medical device that aids in, but does not provide, a diagnosis. It also displays diagnostic quality images for both workstations and mobile platforms. These technological characteristics that comprise the predicate device are substantially similar to the subject device. Therefore, we conclude that the intended use and technological characteristics of CloudVue are substantially equivalent to those of the predicate device, and do not pose any new issues of safety or effectiveness.