K233027
- 510(k) number
- K233027
- Device name
- NanoZoomer S360MD Slide scanner system
- Applicant
- Hamamatsu Photonics K.K. JP
- Product code
- PSY — Whole Slide Imaging System
- Decision date
- 2023-12-22
- Date received
- 2023-09-25
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Advisory committee
- Pathology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K233027.pdf
Official FDA record: K233027
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.