Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

NanoZoomer S540MD Slide Scanner System

K-Number: K260964 · 2026-07-22

ApplicantHamamatsu Photonics K.K.
Decision Date2026-07-22
Product CodePSY
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

NanoZoomer S540MD Slide Scanner System is the device name listed in this FDA 510(k) record. The listed applicant is Hamamatsu Photonics K.K.. It received FDA 510(k) clearance on 2026-07-22 under 510(k) number K260964. The device is classified under product code PSY. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NanoZoomer S540MD Slide Scanner System?

NanoZoomer S540MD Slide Scanner System is a medical device that received FDA 510(k) clearance on 2026-07-22. The listed applicant is Hamamatsu Photonics K.K.. The 510(k) number is K260964.

When did NanoZoomer S540MD Slide Scanner System receive FDA 510(k) clearance?

NanoZoomer S540MD Slide Scanner System received FDA 510(k) clearance on 2026-07-22, under 510(k) number K260964.

Who is the listed applicant for NanoZoomer S540MD Slide Scanner System?

The FDA 510(k) record lists Hamamatsu Photonics K.K. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NanoZoomer S540MD Slide Scanner System?

The FDA product code for NanoZoomer S540MD Slide Scanner System is PSY.

Other records listing Hamamatsu Photonics K.K. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253606NanoZoomer S20MD Slide scanner system; NanoZoomer S360MD Slide scanner systemK233027NanoZoomer S360MD Slide scanner systemK213883NanoZoomer S360MD Slide scanner systemK162117NIRO-200NX DP

Related Devices (Code: PSY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251952VirasightVirasoft CorporationK253606NanoZoomer S20MD Slide scanner system; NanoZoomer S360MD Slide scanner systemHamamatsu Photonics K.K.K243871Philips IntelliSite Pathology Solution 5.1Philips Medical Systems Nederland B.V.K241717E1000 Dx Digital Pathology SolutionShandon Diagnostics LimitedK242783Roche Digital Pathology DxVentana Medical Systems, Inc.K242848Philips IntelliSite Pathology Solution 5.1Philips Medical Systems Nederland B.V.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑