FDA 510(k)

心見心臟P.E.T.處理軟體

K 號：K181343 · 2018-06-12

決定日期2018-06-12

產品代碼KPS

諮詢委員會RA

決定相當於

器材摘要

HeartSee Cardiac P.E.T. Processing Software is the device name listed in this FDA 510(k) record. The listed applicant is Bracco Diagnostics, Inc.. It received FDA 510(k) clearance on 2018-06-12 under 510(k) number K181343. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the HeartSee Cardiac P.E.T. Processing Software?

HeartSee Cardiac P.E.T. Processing Software is a medical device that received FDA 510(k) clearance on 2018-06-12. The listed applicant is Bracco Diagnostics, Inc.. The 510(k) number is K181343.

When did HeartSee Cardiac P.E.T. Processing Software receive FDA 510(k) clearance?

HeartSee Cardiac P.E.T. Processing Software received FDA 510(k) clearance on 2018-06-12, under 510(k) number K181343.

Who is the listed applicant for HeartSee Cardiac P.E.T. Processing Software?

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

What is the FDA product code for HeartSee Cardiac P.E.T. Processing Software?

The FDA product code for HeartSee Cardiac P.E.T. Processing Software is KPS.

其他以 Bracco Diagnostics, 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。

K243881HeartSee™ 心臟灌注顯示 P.E.T. 處理軟體，用於心肌灌注和冠狀血流儲備（CFR）版本 4

相關器械（代碼：KPS）

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。

官方來源

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