FDA 510(k)

Deepsight NeedleVue LC1 Ultrasound System

Número K: K250381 · 2025-08-01

Data da decisão2025-08-01

Código do produtoIYO

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Deepsight NeedleVue LC1 Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is DeepSight Technology, Inc.. It received FDA 510(k) clearance on 2025-08-01 under 510(k) number K250381. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Deepsight NeedleVue LC1 Ultrasound System?

Deepsight NeedleVue LC1 Ultrasound System is a medical device that received FDA 510(k) clearance on 2025-08-01. The listed applicant is DeepSight Technology, Inc.. The 510(k) number is K250381.

When did Deepsight NeedleVue LC1 Ultrasound System receive FDA 510(k) clearance?

Deepsight NeedleVue LC1 Ultrasound System received FDA 510(k) clearance on 2025-08-01, under 510(k) number K250381.

Who is the listed applicant for Deepsight NeedleVue LC1 Ultrasound System?

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

What is the FDA product code for Deepsight NeedleVue LC1 Ultrasound System?

The FDA product code for Deepsight NeedleVue LC1 Ultrasound System is IYO.

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