HOROS MOBILE

GUDID 05070002336815

The Falcon Mobile (MD) is an interactive medical image display software device for diagnostic image viewing of radiological images for the following modalities: X-ray, CT, MRI, Ultrasound, and XA for iOS and iPadOS platforms. The technological characteristics and the indications of use are identical to those of the Horos MD™ (K232589). The subject device provides both 2D and 3D image visualization tools for CT and MRI scans from various makes and models of image acquisition hardware. It does not produce any original medical images and does not contain controls for the direct operation of a diagnostic imaging system. The device is intended to be operated by radiologists, clinicians and other qualified physicians.

ICAT SOLUTIONS LTD

Radiology picture archiving and communication system workstation

• Primary Device ID: 05070002336815
• NIH Device Record Key: fec49b84-b8c2-4182-9a24-b519bdcee418
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HOROS MOBILE
• Version Model Number: HOROS MOBILE
• Company DUNS: 219621409
• Company Name: ICAT SOLUTIONS LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05070002336815 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242552

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-04-30
• Device Publish Date: 2025-04-22

Devices Manufactured by ICAT SOLUTIONS LTD

• 05070002336815 - HOROS MOBILE: 2025-04-30The Falcon Mobile (MD) is an interactive medical image display software device for diagnostic image viewing of radiological images for the following modalities: X-ray, CT, MRI, Ultrasound, and XA for iOS and iPadOS platforms. The technological characteristics and the indications of use are identical to those of the Horos MD™ (K232589). The subject device provides both 2D and 3D image visualization tools for CT and MRI scans from various makes and models of image acquisition hardware. It does not produce any original medical images and does not contain controls for the direct operation of a diagnostic imaging system. The device is intended to be operated by radiologists, clinicians and other qualified physicians.
• 05070002336815 - HOROS MOBILE: 2025-04-30 The Falcon Mobile (MD) is an interactive medical image display software device for diagnostic image viewing of radiological imag
• 05070002336808 - HOROS MD: 2024-01-29 The Horos MD™ is an interactive image display and navigation software device for diagnosis of medical images. It provides both