FDA 510(k)

OARtrac System with Patient Specific Reusable Universal PSD Sensors

Номер K: K162954 · 2017-06-01

Дата решения2017-06-01

Код продуктаNZT

Консультативный комитетRA

РешениеSubstantially Equivalent

Описание устройства

OARtrac System with Patient Specific Reusable Universal PSD Sensors is the device name listed in this FDA 510(k) record. The listed applicant is Radiadyne, LLC. It received FDA 510(k) clearance on 2017-06-01 under 510(k) number K162954. The device is classified under product code NZT. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the OARtrac System with Patient Specific Reusable Universal PSD Sensors?

OARtrac System with Patient Specific Reusable Universal PSD Sensors is a medical device that received FDA 510(k) clearance on 2017-06-01. The listed applicant is Radiadyne, LLC. The 510(k) number is K162954.

When did OARtrac System with Patient Specific Reusable Universal PSD Sensors receive FDA 510(k) clearance?

OARtrac System with Patient Specific Reusable Universal PSD Sensors received FDA 510(k) clearance on 2017-06-01, under 510(k) number K162954.

Who is the listed applicant for OARtrac System with Patient Specific Reusable Universal PSD Sensors?

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

What is the FDA product code for OARtrac System with Patient Specific Reusable Universal PSD Sensors?

The FDA product code for OARtrac System with Patient Specific Reusable Universal PSD Sensors is NZT.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Связанные устройства (Код: NZT)

K250083PRO-DOSE SystemNu-Rise, SA K182395OARtrac SystemRadialdyne, LLC

Официальный источник

Посмотреть в базе данных FDA →

Данные получены из открытого API FDA. Для получения наиболее актуальной и авторитетной информации всегда обращайтесь к официальным записям.