Certifications
Falcon MD is an FDA-cleared Device
K232589
Trade Name: Falcon MD™
Device Name: Horos MD™ (code-name under which the device was cleared)
Regulation Number: 21 CFR 892.2050
Regulation Name: Medical Image Management And Processing System
Regulatory Class: Class II
Product Code: LLZ
Dated: December 13, 2023
Received: December 13, 2023
Falcon MD 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 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 monitor (display) quality, ambient light conditions, and image compression ratios are consistent with the clinical application.
Prescription Use Only (Part 21 CFR Subpart C)
Indications for Use
Falcon MD Mobile is an FDA-cleared Device
K242552
Trade Name: Falcon MD Mobile
Device Name: Horos Mobile™ (code-name under which the device was cleared)
Regulation Number: 21 CFR 892.2050
Regulation Name: Medical Image Management And Processing System
Regulatory Class: Class II
Product Code: LLZ
Dated: April 8, 2025
Received: April 8, 2025
Indications for Use
Falcon MD 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.
Prescription Use Only (Part 21 CFR Subpart C)