# K161515: eUnity

- Pathway: 510(k) (Special)
- Applicant: Client Outlook, Inc.
- Decided: Nov 15, 2016 after 166 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
No predicates in its family tree.
6 later devices descend from it; 1 cites 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K172490: eUnity (2018), 5 descendants of its own
- 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

## Indications for use
eUnity is a software application that displays medical image data and associated clinical reports. eUnity 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 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 used for reading medical images for diagnostic purposes must comply with applicable regulatory approvals and with quality control requirements for their use and maintenance.

Source page: https://510kreport.com/device/K161515
Methodology: https://510kreport.com/methodology