FDA 510(k)

Добавленные Экраны Для FDA Утвержденного HeartSee Кардиак П.Э.Т. Обработка Программного Обеспечения K143664

Номер K: K171303 · 2017-09-22

ЗаявительUniversity of Texas Medical School AT Houston, Texas

Дата решения2017-09-22

Код продуктаKPS

Консультативный комитетRA

РешениеSubstantially Equivalent

Описание устройства

Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664 is the device name listed in this FDA 510(k) record. The listed applicant is University of Texas Medical School AT Houston, Texas. It received FDA 510(k) clearance on 2017-09-22 under 510(k) number K171303. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664?

Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664 is a medical device that received FDA 510(k) clearance on 2017-09-22. The listed applicant is University of Texas Medical School AT Houston, Texas. The 510(k) number is K171303.

When did Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664 receive FDA 510(k) clearance?

Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664 received FDA 510(k) clearance on 2017-09-22, under 510(k) number K171303.

Who is the listed applicant for Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664?

The FDA 510(k) record lists University of Texas Medical School AT Houston, Texas as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664?

The FDA product code for Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664 is KPS.

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: KPS)

Официальный источник

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