# K203058: CloudVue

- Pathway: 510(k) (Traditional)
- Applicant: International Medical Solutions, Inc.
- Decided: Oct 29, 2020 after 21 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K161515 (2016). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172490: eUnity, Client Outlook, Inc. (2018) Summary page 4.

## 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. 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.

Source page: https://510kreport.com/device/K203058
Methodology: https://510kreport.com/methodology