K242783
- 510(k) number
- K242783
- Device name
- Roche Digital Pathology Dx
- Applicant
- Ventana Medical Systems, Inc. AZ · US
- Product code
- PSY — Whole Slide Imaging System
- Decision date
- 2024-12-17
- Date received
- 2024-09-16
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Pathology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K242783.pdf
Official FDA record: K242783
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.