Horos MD – FDA Device Name Information
“Horos MD” is the code name under which this software was cleared by the U.S. Food and Drug Administration.
The code name was used solely for regulatory identification in FDA clearance records.
The software is now developed and distributed under the commercial name Falcon MD. The change in name reflects independent product naming and ongoing regulatory maintenance.
FDA Regulatory Reference
The U.S. FDA clearance for this software was granted under the device name
Horos MD
FDA 510(k) clearance number
K232589
Current commercial name
Falcon MD
Falcon MD is the commercial name under which the software is currently distributed.
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