# K223425: MD.ai Viewer

- Pathway: 510(k) (Traditional)
- Applicant: Mdai, Inc.
- Decided: Feb 10, 2023 after 88 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.
1 later device descends from it; 1 cites it directly.
0 of 4 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 5.

## Most influential descendants
- K233331: MediOMx (2024), 0 descendants of its own

## Indications for use
MD.ai Viewer is a software-based viewer intended to be used with off-the-shelf hardware for the display of DICOM and non-DICOM medical images and other healthcare data to aid in diagnosis for healthcare professionals. It performs operations relating to the transfer, storage, display, and measurement of image data. MD.ai Viewer allows users to perform image manipulations, including window/level, rotation, measurement and markup. MD.ai Viewer provides 2D display, Multi-Planar Reformatting and 3D visualization of medical image data. Mobile usage is for reference and referral only. MD.ai Viewer is not intended for primary mammography interpretation.

Source page: https://510kreport.com/device/K223425
Methodology: https://510kreport.com/methodology