K241232
- 510(k) number
- K241232
- Device name
- Galen Second Read
- Applicant
- Ibex Medical Analytics , Ltd. IL
- Product code
- QPN — Software Algorithm Device To Assist Users In Digital
- Decision date
- 2025-01-24
- Date received
- 2024-05-02
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Pathology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K241232.pdf
Official FDA record: K241232
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.