# K172490: eUnity

- Pathway: 510(k) (Traditional)
- Applicant: Client Outlook, Inc.
- Decided: Feb 6, 2018 after 173 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: 1 generation back to K161515 (2016). 1 ancestor in all.
5 later devices descend from it; 4 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161515: eUnity, Client Outlook, Inc. (2016) Summary page 4.

## Most influential descendants
- K223425: MD.ai Viewer (2023), 1 descendant of its own
- K251881: HippoMind (v1.0) (2025), 0 descendants of its own
- K240724: SynthVISION 1.0.0 (2024), 0 descendants of its own
- K233331: MediOMx (2024), 0 descendants of its own
- K203058: CloudVue (2020), 0 descendants of its own

## Indications for use
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. 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 when a full workstation is not available. Mobile usage for mammography is for reference and referral only.

Source page: https://510kreport.com/device/K172490
Methodology: https://510kreport.com/methodology