FDA 510(k)

ニューロ・アラゴム・アルゴリズム

K番号: K200750 · 2020-11-06

決定日2020-11-06

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Substantially Equivalent

医療機器の概要

Neuro.Al Algorithm is the device name listed in this FDA 510(k) record. The listed applicant is Terarecon,Inc.. It received FDA 510(k) clearance on 2020-11-06 under 510(k) number K200750. 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 Neuro.Al Algorithm?

Neuro.Al Algorithm is a medical device that received FDA 510(k) clearance on 2020-11-06. The listed applicant is Terarecon,Inc.. The 510(k) number is K200750.

When did Neuro.Al Algorithm receive FDA 510(k) clearance?

Neuro.Al Algorithm received FDA 510(k) clearance on 2020-11-06, under 510(k) number K200750.

Who is the listed applicant for Neuro.Al Algorithm?

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

What is the FDA product code for Neuro.Al Algorithm?

The FDA product code for Neuro.Al Algorithm is LLZ.

申請者としてTerarecon,Inc.を記載するその他の記録

K250288TeraRecon Cardiovascular.Calcification.CT K243158TeraRecon Aorta.CT (1.1.0)K241312TeraRecon Cardiac.Chambers.MR (1.0.0)K220349TeraRecon Neuro K191585iNtuition-Structural Heart Module K180916iNtuition-T1 Mapping and T2/T2* Mapping

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