FDA 510(k)

VivoSight Dx Topical OCT System

Номер K: K153283 · 2016-08-11

Дата решения2016-08-11

Код продуктаNQQ

Консультативный комитетRA

РешениеSubstantially Equivalent

Описание устройства

VivoSight Dx Topical OCT System is the device name listed in this FDA 510(k) record. The listed applicant is Michelson Diagnostics, Ltd.. It received FDA 510(k) clearance on 2016-08-11 under 510(k) number K153283. The device is classified under product code NQQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the VivoSight Dx Topical OCT System?

VivoSight Dx Topical OCT System is a medical device that received FDA 510(k) clearance on 2016-08-11. The listed applicant is Michelson Diagnostics, Ltd.. The 510(k) number is K153283.

When did VivoSight Dx Topical OCT System receive FDA 510(k) clearance?

VivoSight Dx Topical OCT System received FDA 510(k) clearance on 2016-08-11, under 510(k) number K153283.

Who is the listed applicant for VivoSight Dx Topical OCT System?

The FDA 510(k) record lists Michelson Diagnostics, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VivoSight Dx Topical OCT System?

The FDA product code for VivoSight Dx Topical OCT System is NQQ.

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: NQQ)

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Официальный источник

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