FDA 510(k)

ビュテリアCT心臓分析

K番号: K222662 · 2022-10-14

決定日2022-10-14

製品コードLLZ

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

Vitrea CT Cardiac Analysis is the device name listed in this FDA 510(k) record. The listed applicant is Canon Medical Informatics, Inc.. It received FDA 510(k) clearance on 2022-10-14 under 510(k) number K222662. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Vitrea CT Cardiac Analysis?

Vitrea CT Cardiac Analysis is a medical device that received FDA 510(k) clearance on 2022-10-14. The listed applicant is Canon Medical Informatics, Inc.. The 510(k) number is K222662.

When did Vitrea CT Cardiac Analysis receive FDA 510(k) clearance?

Vitrea CT Cardiac Analysis received FDA 510(k) clearance on 2022-10-14, under 510(k) number K222662.

Who is the listed applicant for Vitrea CT Cardiac Analysis?

The FDA 510(k) record lists Canon Medical Informatics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vitrea CT Cardiac Analysis?

The FDA product code for Vitrea CT Cardiac Analysis is LLZ.

申請者としてCanon Medical Informatics, Inc.を記載するその他の記録

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