FDA 510(k)

E1000 Dx Digital Pathology Solution

Número K: K241717 · 2025-02-28

Data da decisão2025-02-28

Código do produtoPSY

Comité consultivoPA

DecisãoSubstantially Equivalent

Resumo do dispositivo

E1000 Dx Digital Pathology Solution is the device name listed in this FDA 510(k) record. The listed applicant is Shandon Diagnostics Limited. It received FDA 510(k) clearance on 2025-02-28 under 510(k) number K241717. 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 E1000 Dx Digital Pathology Solution?

E1000 Dx Digital Pathology Solution is a medical device that received FDA 510(k) clearance on 2025-02-28. The listed applicant is Shandon Diagnostics Limited. The 510(k) number is K241717.

When did E1000 Dx Digital Pathology Solution receive FDA 510(k) clearance?

E1000 Dx Digital Pathology Solution received FDA 510(k) clearance on 2025-02-28, under 510(k) number K241717.

Who is the listed applicant for E1000 Dx Digital Pathology Solution?

The FDA 510(k) record lists Shandon Diagnostics Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for E1000 Dx Digital Pathology Solution?

The FDA product code for E1000 Dx Digital Pathology Solution is PSY.

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