FDA 510(k)

Deepsight NeedleVue LC1 Ultrasound System

Номер K: K250381 · 2025-08-01

Дата решения2025-08-01

Код продуктаIYO

Консультативный комитетRA

РешениеSubstantially Equivalent

Описание устройства

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.

Часто задаваемые вопросы

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.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: IYO)

K260313MD-6000S Bladder ScannerMEDA Co., Ltd.K253452Accuro 3SRivanna Medical, Inc.K260190ARTHURROPCA ApS K252237EdgeFlow UW20Edgecare, Inc.K254021Accuro XVRivanna Medical, Inc.K253898QT Scanner 2000 Model AQT Imaging Holdings, Inc.

Официальный источник

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