FDA 510(k)

NanoZoomer S540MD Slide Scanner System

Número K: K260964 · 2026-07-22

Data da decisão2026-07-22

Código do produtoPSY

Comité consultivoPA

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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Outros registros que listam Hamamatsu Photonics K.K. como candidato(a)

K253606NanoZoomer S20MD Slide scanner system; NanoZoomer S360MD Slide scanner system K233027NanoZoomer S360MD Slide scanner system K213883NanoZoomer S360MD Slide scanner system K162117NIRO-200NX DP

Dispositivos Relacionados (Código: PSY)

K253554Aperio GT 450 DX; Aperio GT 180 DXLeica Biosystems Imaging, Inc.K251952VirasightVirasoft Corporation K253606NanoZoomer 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 Limited K242783Roche Digital Pathology DxVentana Medical Systems, Inc.

Fonte oficial

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