FDA 510(k)

デジタルレントゲンシステム（MobileApex 60E、MobileApex 60F、MobileApex 60G、MobileApex 60H）

K番号: K240284 · 2024-03-28

決定日2024-03-28

製品コードIZL

諮問委員会RA （注：由于原文中未提供具体的医疗设备监管文本内容，因此无法进行翻译。请提供具体的文本内容以便进行翻译。）

決定大幅同等

医療機器の概要

Digital Radiography System (MobileApex 60E, MobileApex 60F, MobileApex 60G, MobileApex 60H) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Browiner Tech Co., Ltd.. It received FDA 510(k) clearance on 2024-03-28 under 510(k) number K240284. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Digital Radiography System (MobileApex 60E, MobileApex 60F, MobileApex 60G, MobileApex 60H)?

Digital Radiography System (MobileApex 60E, MobileApex 60F, MobileApex 60G, MobileApex 60H) is a medical device that received FDA 510(k) clearance on 2024-03-28. The listed applicant is Shenzhen Browiner Tech Co., Ltd.. The 510(k) number is K240284.

When did Digital Radiography System (MobileApex 60E, MobileApex 60F, MobileApex 60G, MobileApex 60H) receive FDA 510(k) clearance?

Digital Radiography System (MobileApex 60E, MobileApex 60F, MobileApex 60G, MobileApex 60H) received FDA 510(k) clearance on 2024-03-28, under 510(k) number K240284.

Who is the listed applicant for Digital Radiography System (MobileApex 60E, MobileApex 60F, MobileApex 60G, MobileApex 60H)?

The FDA 510(k) record lists Shenzhen Browiner Tech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Digital Radiography System (MobileApex 60E, MobileApex 60F, MobileApex 60G, MobileApex 60H)?

The FDA product code for Digital Radiography System (MobileApex 60E, MobileApex 60F, MobileApex 60G, MobileApex 60H) is IZL.

申請者としてShenzhen Browiner Tech Co., Ltd.を記載するその他の記録

K240841デジタルレントゲンシステム（ManntiX B、ManntiX K）

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