K241717
- 510(k) number
- K241717
- Device name
- E1000 Dx Digital Pathology Solution
- Applicant
- Shandon Diagnostics Limited GB
- Product code
- PSY — Whole Slide Imaging System
- Decision date
- 2025-02-28
- Date received
- 2024-06-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Pathology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K241717.pdf
Official FDA record: K241717
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.