K232208
- 510(k) number
- K232208
- Device name
- Sectra Digital Pathology Module (Version 3.3)
- Applicant
- Sectra AB SE
- Product code
- PSY — Whole Slide Imaging System
- Decision date
- 2024-04-16
- Date received
- 2023-07-26
- 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: K232208.pdf
Official FDA record: K232208
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.