# K233331: MediOMx

- Pathway: 510(k) (Traditional)
- Applicant: Pmx, Inc.
- Decided: Jun 17, 2024 after 262 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: 3 generations back to K161515 (2016). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223425: MD.ai Viewer, Mdai, Inc. (2023) Summary page 4.

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

Source page: https://510kreport.com/device/K233331
Methodology: https://510kreport.com/methodology