FDA UDI In Commercial Distribution 🇺🇸 United States

CloudVue

DI: 10628634297015 · Model: 0601 · International Medical Solutions Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
CloudVue
Primary DI
10628634297015
Version / Model
0601
Company Name
International Medical Solutions Inc
Labeler DUNS
203073770
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-12-04
Public Version
2
Public Version Date
2023-10-18
Public Version Status
Update
Public Device Record Key
b01c2a00-6dbf-41d3-9bbb-abd3d8849fc3

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 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.

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
LLZ System, Image Processing, Radiological

GMDN Terms

Code Name
41670 Radiological PACS software

Identifiers

Type ID
Primary 10628634297015

Premarket Submissions

Submission Number Supplement Number
K203058 000