FDA 510(k)

VistaScan USB Ultrasound Imaging System

Номер K: K192170 · 2020-01-23

ЗаявительEmagine Solutions Technology, LLC

Дата решения2020-01-23

Код продуктаIYO

Консультативный комитетRA

РешениеSubstantially Equivalent

Описание устройства

VistaScan USB Ultrasound Imaging System is the device name listed in this FDA 510(k) record. The listed applicant is Emagine Solutions Technology, LLC. It received FDA 510(k) clearance on 2020-01-23 under 510(k) number K192170. 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 VistaScan USB Ultrasound Imaging System?

VistaScan USB Ultrasound Imaging System is a medical device that received FDA 510(k) clearance on 2020-01-23. The listed applicant is Emagine Solutions Technology, LLC. The 510(k) number is K192170.

When did VistaScan USB Ultrasound Imaging System receive FDA 510(k) clearance?

VistaScan USB Ultrasound Imaging System received FDA 510(k) clearance on 2020-01-23, under 510(k) number K192170.

Who is the listed applicant for VistaScan USB Ultrasound Imaging System?

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

What is the FDA product code for VistaScan USB Ultrasound Imaging System?

The FDA product code for VistaScan USB Ultrasound Imaging 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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