NanoZoomer S360MD Slide scanner system— 510(k) K213883

Name: FDA 510(k) clearance K213883
Creator: U.S. Food and Drug Administration
Published: 2022-09-27

Substantially Equivalent

Hamamatsu Photonics K.K.

FDA 510(k) clearance K213883 for NanoZoomer S360MD Slide scanner system, Substantially Equivalent on 2022-09-27. 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: 2021-12-13
Decision date: 2022-09-27
Decision: Substantially Equivalent
Clearance type: Traditional
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
K253606 — NanoZoomer S20MD Slide scanner system; NanoZoomer S360MD Slide scanner system2026-07-15
K243871 — Philips IntelliSite Pathology Solution 5.12025-03-06

More clearances from Hamamatsu Photonics K.K.

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K233027 — NanoZoomer S360MD Slide scanner system2023-12-22
K162117 — NIRO-200NX DP2016-10-25
K143219 — NIRO-200NX2015-07-31
K133719 — PDE-NEO2014-03-27
K110480 — PDE PHOTODYNAMIC EYE2012-01-13

Recalls naming K213883

K-number listed on FDA's recall record

Z-2280-2023 — NanoZoomer S360MD Slide scanner system-automated system for creating, viewing, and managing digital slides. The NanoZoomer System creates diagnostic-quality digital images of glass slides containing formalin-fixed paraffin-embedded (FFPE) tissue. Catalog Number: C13220-01MDClass II·Ongoing·Hamamatsu Corporation·20230606

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K213883.

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