DEVICE: CloudVue (10628634297015)

Device Identifier (DI) Information

CloudVue
0601
In Commercial Distribution

International Medical Solutions Inc
10628634297015
GS1

1
203073770 *Terms of Use
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 2nd generation and higher, and iPad Air 3 and higher. This level of portability allows healthcare professionals to access their medical image data anytime, anywhere.
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Device Characteristics

Labeling does not contain MRI Safety Information
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No
Yes
Yes
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No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
41670 Radiological PACS software
An individual software application intended to be installed on a central server as part of a picture archiving and communication system (PACS) to allow storage, retrieval, analysis, and management of radiological images.
Active false
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FDA Product Code

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Product Code Product Code Name
LLZ System, Image Processing, Radiological
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K203058 000
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

b01c2a00-6dbf-41d3-9bbb-abd3d8849fc3
October 18, 2023
2
December 04, 2020
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
Yes
No
No
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Customer Contact

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No Customer Contact currently defined
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