K232589
- 510(k) number
- K232589
- Device name
- Horos MD
- Applicant
- Icat Solutions, Ltd. GB
- Product code
- LLZ — System, Image Processing, Radiological
- Decision date
- 2024-01-03
- Date received
- 2023-08-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 1.8 MB · U.S. public domain
Also available from FDA: K232589.pdf
Official FDA record: K232589
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.