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.

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: 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 ↗

Recent devices under product code PSY

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K253554 — Aperio GT 450 DX; Aperio GT 180 DX2026-08-07
K260964 — NanoZoomer S540MD Slide Scanner System2026-07-22
K251952 — Virasight2026-07-17
K243871 — Philips IntelliSite Pathology Solution 5.12025-03-06
K241717 — E1000 Dx Digital Pathology Solution2025-02-28

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.