FDA 510(k)

SMD-Sr90-DA Radionuclide Brachytherapy Source

Номер K: K163206 · 2016-12-15

ЗаявительSalutaris Medical Devices, Inc.

Дата решения2016-12-15

Код продуктаKXK

Консультативный комитетRA

РешениеSubstantially Equivalent

Описание устройства

SMD-Sr90-DA Radionuclide Brachytherapy Source is the device name listed in this FDA 510(k) record. The listed applicant is Salutaris Medical Devices, Inc.. It received FDA 510(k) clearance on 2016-12-15 under 510(k) number K163206. The device is classified under product code KXK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the SMD-Sr90-DA Radionuclide Brachytherapy Source?

SMD-Sr90-DA Radionuclide Brachytherapy Source is a medical device that received FDA 510(k) clearance on 2016-12-15. The listed applicant is Salutaris Medical Devices, Inc.. The 510(k) number is K163206.

When did SMD-Sr90-DA Radionuclide Brachytherapy Source receive FDA 510(k) clearance?

SMD-Sr90-DA Radionuclide Brachytherapy Source received FDA 510(k) clearance on 2016-12-15, under 510(k) number K163206.

Who is the listed applicant for SMD-Sr90-DA Radionuclide Brachytherapy Source?

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

What is the FDA product code for SMD-Sr90-DA Radionuclide Brachytherapy Source?

The FDA product code for SMD-Sr90-DA Radionuclide Brachytherapy Source is KXK.

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: KXK)

K252296OncoPatchOncopatch, Inc.K242818IsoSphereIsoaid, LLC K223465RadianceTx Radionuclide Brachytherapy SourceRadiance Therapeutics, Inc.K221539GammaTileGt Medical Technologies K202267Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge NeedlesIsoray Medical, Inc.K193602LV Liberty Vision Model 1 90Yttrium Brachytherapy SourceLv Liberty Vision Corporation

Официальный источник

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