Horos MD™
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
Indications for Use
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)