FDA 510(k)

LV Liberty Vision Model 1 90Yttrium Brachytherapy Source

Номер K: K193602 · 2020-05-29

Дата решения2020-05-29

Код продуктаKXK

Консультативный комитетRA

РешениеSubstantially Equivalent

Описание устройства

LV Liberty Vision Model 1 90Yttrium Brachytherapy Source is the device name listed in this FDA 510(k) record. The listed applicant is Lv Liberty Vision Corporation. It received FDA 510(k) clearance on 2020-05-29 under 510(k) number K193602. 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 LV Liberty Vision Model 1 90Yttrium Brachytherapy Source?

LV Liberty Vision Model 1 90Yttrium Brachytherapy Source is a medical device that received FDA 510(k) clearance on 2020-05-29. The listed applicant is Lv Liberty Vision Corporation. The 510(k) number is K193602.

When did LV Liberty Vision Model 1 90Yttrium Brachytherapy Source receive FDA 510(k) clearance?

LV Liberty Vision Model 1 90Yttrium Brachytherapy Source received FDA 510(k) clearance on 2020-05-29, under 510(k) number K193602.

Who is the listed applicant for LV Liberty Vision Model 1 90Yttrium Brachytherapy Source?

The FDA 510(k) record lists Lv Liberty Vision Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LV Liberty Vision Model 1 90Yttrium Brachytherapy Source?

The FDA product code for LV Liberty Vision Model 1 90Yttrium 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.K190839GammaTileGt Medical Technologies

Официальный источник

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