# K242552: Horos Mobile

- Pathway: 510(k) (Traditional)
- Applicant: Icat Solutions, Ltd.
- Decided: Apr 8, 2025 after 224 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: 9 generations back to K942120 (1994). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232589: Horos MD™, Icat Solutions, Ltd. (2024) Summary page 5.

## Indications for use
Horos Mobile is a software device intended for viewing images acquired from computed tomography (CT), computed radiography (CR), magnetic resonance (MR), ultrasound (US) and other DICOM compliant medical imaging systems when installed on suitable commercial standard hardware. Images and data can be stored, communicated, processed, and displayed within the system. It is intended for use as a diagnostic and review tool by trained healthcare professionals. This device is not intended to replace full workstations and should be used only when there is no access to a workstation. This device is not to be used for mammography. It is the User's responsibility to operate the device in accordance with the software and hardware requirements listed in the instructions for use, in particular ensuring that display quality, ambient light conditions, and image compression ratios are consistent with the clinical application.

Source page: https://510kreport.com/device/K242552
Methodology: https://510kreport.com/methodology