FDA 510(k)

歯科用圆锥束CT

K番号: K240855 · 2024-04-25

申請者Yian Medical Technology (Haining) Co., Ltd.

決定日2024-04-25

製品コードOAS

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

Dental Cone-beam Computed Tomography is the device name listed in this FDA 510(k) record. The listed applicant is Yian Medical Technology (Haining) Co., Ltd.. It received FDA 510(k) clearance on 2024-04-25 under 510(k) number K240855. The device is classified under product code OAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Dental Cone-beam Computed Tomography?

Dental Cone-beam Computed Tomography is a medical device that received FDA 510(k) clearance on 2024-04-25. The listed applicant is Yian Medical Technology (Haining) Co., Ltd.. The 510(k) number is K240855.

When did Dental Cone-beam Computed Tomography receive FDA 510(k) clearance?

Dental Cone-beam Computed Tomography received FDA 510(k) clearance on 2024-04-25, under 510(k) number K240855.

Who is the listed applicant for Dental Cone-beam Computed Tomography?

The FDA 510(k) record lists Yian Medical Technology (Haining) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dental Cone-beam Computed Tomography?

The FDA product code for Dental Cone-beam Computed Tomography is OAS.

申請者としてYian Medical Technology (Haining) Co., Ltd.を記載するその他の記録

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