Horos Mobile
iCat Solutions LtdHoros Mobile is a mobile software application that allows trained healthcare professionals to view and review medical images from CT, MRI, X-ray, ultrasound and other DICOM compliant systems on iOS and iPadOS devices. It facilitates diagnostic image visualization remotely or when full workstations are not available, supporting essential tools for image manipulation and measurement consistent with clinical practice requirements.
Intended 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. It is intended for use as a diagnostic and review tool by trained healthcare professionals, not to replace full workstations but to be used when there is no access to a workstation.
Technology
Horos Mobile operates on iOS and iPadOS platforms on commercial hardware such as iPhones and iPads, using DICOM standards for image sharing and viewing. It supports 2D and 3D image visualization tools, including volume rendering and multiplanar reconstruction (MPR). The user interface follows Apple's Human Interface Guidelines to ensure intuitive operation. Software verification and validation testing confirm the device's performance.
Performance
Non-clinical performance testing including software verification and validation, and bench testing for measurement accuracy using digital reference objects showed 100% accuracy for distance, angle, point, and area measurements. Display performance testing on iPhone 14 Pro Max and iPad Pro 12.9-inch following IEC 62563-1 standards demonstrated appropriate luminance response, uniformity, grayscale and contrast resolution, pixel resolution, and angular viewing for diagnostic use.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/27/2024
7 months - 2
FDA Approval
4/8/2025
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