FDA 510(k)

Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M)

Номер K: K251004 · 2025-11-06

ЗаявительHefei Chimed Intelligent Machine Co., Ltd.

Дата решения2025-11-06

Код продуктаOXO

Консультативный комитетRA

РешениеSubstantially Equivalent

Описание устройства

Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M) is the device name listed in this FDA 510(k) record. The listed applicant is Hefei Chimed Intelligent Machine Co., Ltd.. It received FDA 510(k) clearance on 2025-11-06 under 510(k) number K251004. The device is classified under product code OXO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M)?

Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M) is a medical device that received FDA 510(k) clearance on 2025-11-06. The listed applicant is Hefei Chimed Intelligent Machine Co., Ltd.. The 510(k) number is K251004.

When did Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M) receive FDA 510(k) clearance?

Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M) received FDA 510(k) clearance on 2025-11-06, under 510(k) number K251004.

Who is the listed applicant for Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M)?

The FDA 510(k) record lists Hefei Chimed Intelligent Machine Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M)?

The FDA product code for Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M) is OXO.

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: OXO)

K253296Digital C-ARM with 3DAllengers Medical Systems Limited K252579Orthoscan TAU MVP Mini C-Arm SystemZiehm-Orthoscan, Inc.K253269OEC One CFDGe Hualun Medical Systems Co. , Ltd.K250587Orthoscan TAU Mini C-ArmZiehm-Orthoscan, Inc.K243452Orthoscan VERSA Mini C-ArmZiehm-Orthoscan, Inc.K240828OEC One ASDGe Hualun Medical Systems Co. , Ltd.

Официальный источник

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