K260964
- 510(k) number
- K260964
- Device name
- NanoZoomer S540MD Slide Scanner System
- Applicant
- Hamamatsu Photonics K.K. JP
- Product code
- PSY — Whole Slide Imaging System
- Decision date
- 2026-07-22
- Date received
- 2026-03-23
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Advisory committee
- Pathology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K260964.pdf
Official FDA record: K260964
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.