K250414
- 510(k) number
- K250414
- Device name
- CaloPix
- Applicant
- Tribun Health FR
- Product code
- QKQ — Digital Pathology Image Viewing And Management Softw
- Decision date
- 2025-05-14
- Date received
- 2025-02-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Pathology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K250414.pdf
Official FDA record: K250414
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.