Horos Mobile

Horos Mobile is a software application for viewing and processing medical images from CT, MR, CR, US and other DICOM-compliant imaging systems on iOS and iPadOS devices. It provides 2D and 3D visualization, measurement, and annotation tools for diagnostic review by trained healthcare professionals. The device is not intended to replace full workstations and should only be used when workstation access is unavailable.

Horos Mobile runs on iOS/iPadOS handheld devices (iPhone, iPad) using Apple's METAL framework for 3D graphics, whereas the predicate Horos MD™ runs on MacOS computers. Both support identical imaging modalities (CT, MR, CR, DR, US), use DICOM standards, and provide the same core visualization, measurement, and annotation tools. Horos Mobile includes additional features like anonymization and study comparison not present in the reference device Mobile MIM, but these are the same technology as in the predicate.

DICOM standard NEMA PS3.1 2023b; JPEG compression standard IEC/ISO 10918-1 Edition 1 (1994); IEC 62563-1 for display performance bench testing (luminance response per DICOM GSDF, luminance uniformity, greyscale evaluation, contrast resolution, pixel resolution, angular viewing).

Horos Mobile is substantially equivalent because it has identical intended use and indications for use as the predicate Horos MD™—both are diagnostic image viewers for multiple modalities on portable Apple devices. The technological difference (iOS/iPadOS versus MacOS) does not raise safety or effectiveness concerns since bench testing on designated hardware (iPhone 14 Pro Max, iPad Pro 12.9-inch) demonstrated appropriate display performance and measurement accuracy (100% accuracy across 75 test cases). Software verification and validation testing, cybersecurity implementation, and non-clinical performance testing all demonstrate the subject device performs comparably to and is as safe and effective as the predicate.