FDA 510(k)

Precise Treatment System; Synergy platform; Synergy; Infinity; VersaHD

Номер K: K182138 · 2018-09-05

Дата решения2018-09-05

Код продуктаIYE

Консультативный комитетRA

РешениеSubstantially Equivalent

Описание устройства

Precise Treatment System; Synergy platform; Synergy; Infinity; VersaHD is the device name listed in this FDA 510(k) record. The listed applicant is Eleckta Limited. It received FDA 510(k) clearance on 2018-09-05 under 510(k) number K182138. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Precise Treatment System; Synergy platform; Synergy; Infinity; VersaHD?

Precise Treatment System; Synergy platform; Synergy; Infinity; VersaHD is a medical device that received FDA 510(k) clearance on 2018-09-05. The listed applicant is Eleckta Limited. The 510(k) number is K182138.

When did Precise Treatment System; Synergy platform; Synergy; Infinity; VersaHD receive FDA 510(k) clearance?

Precise Treatment System; Synergy platform; Synergy; Infinity; VersaHD received FDA 510(k) clearance on 2018-09-05, under 510(k) number K182138.

Who is the listed applicant for Precise Treatment System; Synergy platform; Synergy; Infinity; VersaHD?

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

What is the FDA product code for Precise Treatment System; Synergy platform; Synergy; Infinity; VersaHD?

The FDA product code for Precise Treatment System; Synergy platform; Synergy; Infinity; VersaHD is IYE.

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: IYE)

K261865AerFrame™ Alignment Laser Box (LBV2)Stabilix, LLC K261718EZFluence (RADEZ V2)Radformation, Inc.K260733MRIA Radiation Therapy Information System (MRIA)Manteia Technologies Co., Ltd.K261856Halcyon, Ethos Radiotherapy System (5.0)Varian Medical Systems, Inc.K252937ThinkQA 3Dosisoft SA K253004LUNA 3DLap GmbH Laser Applikationen

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.