FDA 510(k)

iNtuition-T1對照與T2/T2*對照

K 號：K180916 · 2018-09-24

決定日期2018-09-24

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

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.

常見問題

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.

其他以 Terarecon,Inc. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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相關器械（代碼：LLZ）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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