FDA 510(k)

X-ray Imaging System for the McLaren Proton Treatment System

Номер K: K181498 · 2018-12-10

ЗаявительEhmetdx, LLC

Дата решения2018-12-10

Код продуктаLHN

Консультативный комитетRA

РешениеSubstantially Equivalent

Описание устройства

X-ray Imaging System for the McLaren Proton Treatment System is the device name listed in this FDA 510(k) record. The listed applicant is Ehmetdx, LLC. It received FDA 510(k) clearance on 2018-12-10 under 510(k) number K181498. The device is classified under product code LHN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the X-ray Imaging System for the McLaren Proton Treatment System?

X-ray Imaging System for the McLaren Proton Treatment System is a medical device that received FDA 510(k) clearance on 2018-12-10. The listed applicant is Ehmetdx, LLC. The 510(k) number is K181498.

When did X-ray Imaging System for the McLaren Proton Treatment System receive FDA 510(k) clearance?

X-ray Imaging System for the McLaren Proton Treatment System received FDA 510(k) clearance on 2018-12-10, under 510(k) number K181498.

Who is the listed applicant for X-ray Imaging System for the McLaren Proton Treatment System?

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

What is the FDA product code for X-ray Imaging System for the McLaren Proton Treatment System?

The FDA product code for X-ray Imaging System for the McLaren Proton Treatment System is LHN.

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: LHN)

K260597VIRTUE QAProNova Solutions K260174PROBEAT-CRHitachi High-Tech Corp.K252815ProBeam 360 Proton Therapy System v3.0Varian Medical Systems, Inc.K253406S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)Mevion Medical Systems, Inc.K250986S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)Mevion Medical Systems, Inc.K243900eMotus Respiratory Motion Management SystemEmpnia, Inc.

Официальный источник

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