FDA 510(k)

Sentinella 102, Sentinella 102 Horus

Номер K: K162052 · 2016-08-18

ЗаявительGeneral Equipment For Medical Imaging (Oncovision-

Дата решения2016-08-18

Код продуктаIYX

Консультативный комитетRA

РешениеSubstantially Equivalent

Описание устройства

Sentinella 102, Sentinella 102 Horus is the device name listed in this FDA 510(k) record. The listed applicant is General Equipment For Medical Imaging (Oncovision-. It received FDA 510(k) clearance on 2016-08-18 under 510(k) number K162052. The device is classified under product code IYX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Sentinella 102, Sentinella 102 Horus?

Sentinella 102, Sentinella 102 Horus is a medical device that received FDA 510(k) clearance on 2016-08-18. The listed applicant is General Equipment For Medical Imaging (Oncovision-. The 510(k) number is K162052.

When did Sentinella 102, Sentinella 102 Horus receive FDA 510(k) clearance?

Sentinella 102, Sentinella 102 Horus received FDA 510(k) clearance on 2016-08-18, under 510(k) number K162052.

Who is the listed applicant for Sentinella 102, Sentinella 102 Horus?

The FDA 510(k) record lists General Equipment For Medical Imaging (Oncovision- as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sentinella 102, Sentinella 102 Horus?

The FDA product code for Sentinella 102, Sentinella 102 Horus is IYX.

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: IYX)

K230221QDOSE® Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular Radiotherapy)Versant Medical Physics and Radiation Safety K2125873D-RD-SRadiopharmaceutical Imaging and Dosimetry, LLC K163687OLINDA EXMHermes Medical Solutions AB K160933Discovery NM 750b BopsyGE Healthcare

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