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.

Summary

Hamamatsu Photonics' NanoZoomer S540MD Slide Scanner System is filed under PSY, whole slide imaging systems. The record doesn't give the scanner's specs or list the system's components.

Class II, 21 CFR 864.3700. Pathology is both the classification panel and the review panel. It came in as an Abbreviated 510(k).

Hamamatsu filed from Hamamatsu City, Japan. The decision came 121 calendar days after FDA received it (March 23 to July 22, 2026).

Clearance details

Applicant: Hamamatsu Photonics K.K.
Product code: Product 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.