FDA 510(k)

OptraSCAN System

Número K: K260755 · 2026-07-02

Data da decisão2026-07-02

Código do produtoNOT

Comité consultivoHE

DecisãoSubstantially Equivalent

Resumo do dispositivo

OptraSCAN System is the device name listed in this FDA 510(k) record. The listed applicant is Optrascan, Inc.. It received FDA 510(k) clearance on 2026-07-02 under 510(k) number K260755. The device is classified under product code NOT. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the OptraSCAN System?

OptraSCAN System is a medical device that received FDA 510(k) clearance on 2026-07-02. The listed applicant is Optrascan, Inc.. The 510(k) number is K260755.

When did OptraSCAN System receive FDA 510(k) clearance?

OptraSCAN System received FDA 510(k) clearance on 2026-07-02, under 510(k) number K260755.

Who is the listed applicant for OptraSCAN System?

The FDA 510(k) record lists Optrascan, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OptraSCAN System?

The FDA product code for OptraSCAN System is NOT.

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