NanoZoomer S20MD Slide scanner system; NanoZoomer S360MD Slide scanner system— 510(k) K253606

Name: FDA 510(k) clearance K253606
Creator: U.S. Food and Drug Administration
Published: 2026-07-15

Substantially Equivalent

Hamamatsu Photonics K.K.

FDA 510(k) clearance K253606 for NanoZoomer S20MD Slide scanner system; NanoZoomer S360MD Slide scanner system, Substantially Equivalent on 2026-07-15. Applicant: Hamamatsu Photonics K.K.. Device class: 2.

Summary

Hamamatsu Photonics' clearance covers the NanoZoomer S20MD and NanoZoomer S360MD slide scanner systems, filed under PSY, whole slide imaging systems. The record doesn't say how the two differ.

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

Hamamatsu filed from Hamamatsu City, Japan. Review took 239 calendar days (November 18, 2025 to July 15, 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: 2025-11-18
Decision date: 2026-07-15
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Hamamatsu City, JP

Download summary PDF View on FDA.gov ↗

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More clearances from Hamamatsu Photonics K.K.

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K233027 — NanoZoomer S360MD Slide scanner system2023-12-22
K213883 — NanoZoomer S360MD Slide scanner system2022-09-27
K162117 — NIRO-200NX DP2016-10-25
K143219 — NIRO-200NX2015-07-31
K133719 — PDE-NEO2014-03-27

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