K232879
- 510(k) number
- K232879
- Device name
- Roche Digital Pathology Dx (VENTANA DP 200)
- Applicant
- Ventana Medical Systems, Inc. AZ · US
- Product code
- PSY — Whole Slide Imaging System
- Decision date
- 2024-06-14
- Date received
- 2023-09-18
- 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: K232879.pdf
Official FDA record: K232879
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.