FDA 510(k)

iNtuition-T1 Mapping and T2/T2* Mapping

K番号: K180916 · 2018-09-24

決定日2018-09-24

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

iNtuition-T1 Mapping and T2/T2* Mapping is the device name listed in this FDA 510(k) record. The listed applicant is Terarecon,Inc.. It received FDA 510(k) clearance on 2018-09-24 under 510(k) number K180916. 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 iNtuition-T1 Mapping and T2/T2* Mapping?

iNtuition-T1 Mapping and T2/T2* Mapping is a medical device that received FDA 510(k) clearance on 2018-09-24. The listed applicant is Terarecon,Inc.. The 510(k) number is K180916.

When did iNtuition-T1 Mapping and T2/T2* Mapping receive FDA 510(k) clearance?

iNtuition-T1 Mapping and T2/T2* Mapping received FDA 510(k) clearance on 2018-09-24, under 510(k) number K180916.

Who is the listed applicant for iNtuition-T1 Mapping and T2/T2* Mapping?

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 iNtuition-T1 Mapping and T2/T2* Mapping?

The FDA product code for iNtuition-T1 Mapping and T2/T2* Mapping 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 K200750ニューロ・アラゴム・アルゴリズム K191585iNtuition-Structural Heart Module

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