NanoZoomer S540MD Slide Scanner System— 510(k) K260964

Name: FDA 510(k) clearance K260964
Creator: U.S. Food and Drug Administration
Published: 2026-07-22

Substantially Equivalent

Hamamatsu Photonics K.K.

FDA 510(k) clearance K260964 for NanoZoomer S540MD Slide Scanner System, Substantially Equivalent on 2026-07-22. Applicant: Hamamatsu Photonics K.K.. Device class: 2.

Clearance details

Applicant: Hamamatsu Photonics K.K.
Product code: Code PSY
Device class: Class 2
Regulation: 21 CFR 864.3700
Advisory panel: Pathology
Date received: 2026-03-23
Decision date: 2026-07-22
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Hamamatsu City, JP

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.