ICAT SOLUTIONS LTD

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3030446518	3030446518	ICAT SOLUTIONS LTD	1	N	2026-01-01	51-59 Rose Lane Norwich Norfolk GB NR1 1BY

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
325128	1047644600	K242552	Horos Mobile	LLZ	2025-04-08
325128	2019960963	K232589	Horos MD™	LLZ	2024-01-03

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
LLZ	2	2025-04-08

GUDID#

HOROS MOBILE - The Falcon 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
2025-04-22
HOROS MD - The Horos MD™ is an interactive image display and navigation software device for diagnosis of medical images. It provides both 2D and 3D image visualization tools for CT and MRI scans from different 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. Horos MD™ conforms to the DICOM standard to allow the sharing of medical images with other digital imaging systems such as PACS (Picture Archiving and Communication System). The Horos MD™ software device runs on the macOS X platform, taking advantage of its optimized 3D graphic capabilities, which are provided by the METAL framework developed and maintained by Apple Inc. The user interface of the software follows Apple's Human Interface Guidelines (HIG) in order to create a user interface that is intuitive and easy to use for users who are familiar with other Apple products. Typical users of this device are radiologists and clinicians who are familiar with 2D scan images.
ICAT SOLUTIONS LTD
2024-01-20